Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-05 @ 9:37 AM
Study NCT ID:
NCT00575159
Status:
COMPLETED
Last Update Posted:
2017-10-09
First Post:
2007-12-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately up to 6 months', 'description': 'Safety population was used.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250 milliliter (mL) of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 months', 'description': 'Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all enrolled participants who have received at least one dose of study drug were included in the safety population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Hypoglycemia Episodes/Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of each treatment period', 'description': 'A hypoglycemic event was defined as symptoms of hypoglycemia confirmed by a blood glucose value below normal limits \\[less than 3.89 millimoles per liter (mmol/L)\\] or 70 milligrams per deciliter (mg/dL). Symptoms of hypoglycemia without confirmed blood glucose values were reported as AEs instead of hypoglycemic events. Number of participants with hypoglycemic events were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Vital Signs: Systolic and Diastolic Blood Pressure (SBP and DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'SBP,Day1,0.5 H', 'categories': [{'measurements': [{'value': '1.6', 'spread': '10.63', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '5.32', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '18.03', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '12.97', 'groupId': 'OG003'}, {'value': '-1.9', 'spread': '8.82', 'groupId': 'OG004'}]}]}, {'title': 'SBP,Day1,1 H', 'categories': [{'measurements': [{'value': '1.8', 'spread': '14.70', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '9.17', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '12.78', 'groupId': 'OG002'}, {'value': '-7.8', 'spread': '8.77', 'groupId': 'OG003'}, {'value': '5.6', 'spread': '14.75', 'groupId': 'OG004'}]}]}, {'title': 'SBP,Day1,2 H', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '6.29', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '14.30', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '13.19', 'groupId': 'OG003'}, {'value': '-2.2', 'spread': '9.38', 'groupId': 'OG004'}]}]}, {'title': 'SBP,Day1,4 H', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '11.86', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '7.56', 'groupId': 'OG001'}, {'value': '-8.4', 'spread': '8.37', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '18.52', 'groupId': 'OG003'}, {'value': '-4.3', 'spread': '7.49', 'groupId': 'OG004'}]}]}, {'title': 'SBP,Day1,6 H', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '9.88', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '13.10', 'groupId': 'OG001'}, {'value': '-8.2', 'spread': '7.18', 'groupId': 'OG002'}, {'value': '-8.4', 'spread': '15.43', 'groupId': 'OG003'}, {'value': '-6.9', 'spread': '13.58', 'groupId': 'OG004'}]}]}, {'title': 'SBP,Day1,8 H', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '13.12', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '10.80', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '10.21', 'groupId': 'OG002'}, {'value': '-7.3', 'spread': '18.50', 'groupId': 'OG003'}, {'value': '-2.4', 'spread': '12.56', 'groupId': 'OG004'}]}]}, {'title': 'SBP,Day1,24 H', 'categories': [{'measurements': [{'value': '2.6', 'spread': '7.27', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '11.77', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '9.54', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '12.20', 'groupId': 'OG003'}, {'value': '-4.6', 'spread': '12.85', 'groupId': 'OG004'}]}]}, {'title': 'DBP,Day1,0.5 H', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '10.36', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '9.38', 'groupId': 'OG001'}, {'value': '-9.8', 'spread': '11.73', 'groupId': 'OG002'}, {'value': '-7.4', 'spread': '13.13', 'groupId': 'OG003'}, {'value': '-5.2', 'spread': '13.36', 'groupId': 'OG004'}]}]}, {'title': 'DBP,Day1,1 H', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '11.61', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '12.31', 'groupId': 'OG001'}, {'value': '-11.5', 'spread': '8.32', 'groupId': 'OG002'}, {'value': '-15.1', 'spread': '11.06', 'groupId': 'OG003'}, {'value': '-5.7', 'spread': '9.59', 'groupId': 'OG004'}]}]}, {'title': 'DBP,Day1,2 H', 'categories': [{'measurements': [{'value': '-8.8', 'spread': '7.50', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '11.29', 'groupId': 'OG001'}, {'value': '-11.7', 'spread': '10.04', 'groupId': 'OG002'}, {'value': '-11.0', 'spread': '12.72', 'groupId': 'OG003'}, {'value': '-7.2', 'spread': '10.55', 'groupId': 'OG004'}]}]}, {'title': 'DBP,Day1,4 H', 'categories': [{'measurements': [{'value': '-6.4', 'spread': '7.52', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '13.08', 'groupId': 'OG001'}, {'value': '-11.7', 'spread': '7.45', 'groupId': 'OG002'}, {'value': '-8.5', 'spread': '13.04', 'groupId': 'OG003'}, {'value': '-7.7', 'spread': '9.84', 'groupId': 'OG004'}]}]}, {'title': 'DBP,Day1,6 H', 'categories': [{'measurements': [{'value': '-8.4', 'spread': '8.88', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '10.70', 'groupId': 'OG001'}, {'value': '-13.2', 'spread': '8.31', 'groupId': 'OG002'}, {'value': '-12.3', 'spread': '15.36', 'groupId': 'OG003'}, {'value': '-8.0', 'spread': '12.91', 'groupId': 'OG004'}]}]}, {'title': 'DBP,Day1,8 H', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '7.79', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '9.24', 'groupId': 'OG001'}, {'value': '-10.1', 'spread': '5.76', 'groupId': 'OG002'}, {'value': '-10.7', 'spread': '15.40', 'groupId': 'OG003'}, {'value': '-4.7', 'spread': '15.05', 'groupId': 'OG004'}]}]}, {'title': 'DBP,Day1,24 H', 'categories': [{'measurements': [{'value': '0.5', 'spread': '9.97', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '11.55', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '6.71', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '11.51', 'groupId': 'OG003'}, {'value': '-2.0', 'spread': '9.51', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each treatment period', 'description': 'SBP and DBP were obtained during each treatment period at the indicated time points. Measurements were made with the participant lying semi-recumbent having rested in this position for at least 10 minute before the initial reading.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Vital Signs: Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'Day 1,0.5 H', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '9.69', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '8.57', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '7.21', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '7.58', 'groupId': 'OG003'}, {'value': '-5.2', 'spread': '12.67', 'groupId': 'OG004'}]}]}, {'title': 'Day 1,1 H', 'categories': [{'measurements': [{'value': '1.7', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '8.65', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '8.23', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '11.20', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '12.96', 'groupId': 'OG004'}]}]}, {'title': 'Day 1,2 H', 'categories': [{'measurements': [{'value': '1.0', 'spread': '13.79', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '7.90', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '8.22', 'groupId': 'OG002'}, {'value': '-3.3', 'spread': '7.42', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '14.05', 'groupId': 'OG004'}]}]}, {'title': 'Day 1,4 H', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '10.46', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '7.94', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '9.79', 'groupId': 'OG003'}, {'value': '-6.8', 'spread': '10.90', 'groupId': 'OG004'}]}]}, {'title': 'Day 1,6 H', 'categories': [{'measurements': [{'value': '2.5', 'spread': '11.20', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '8.46', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '10.36', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '11.54', 'groupId': 'OG003'}, {'value': '-1.4', 'spread': '12.17', 'groupId': 'OG004'}]}]}, {'title': 'Day 1,8 H', 'categories': [{'measurements': [{'value': '0.7', 'spread': '12.48', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '10.60', 'groupId': 'OG001'}, {'value': '-4.6', 'spread': '6.95', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '10.16', 'groupId': 'OG003'}, {'value': '-3.4', 'spread': '12.04', 'groupId': 'OG004'}]}]}, {'title': 'Day 1,24 H', 'categories': [{'measurements': [{'value': '5.4', 'spread': '13.92', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '11.67', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '10.99', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '11.50', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '12.39', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Heart rate was obtained during each treatment period at indicated time points. Measurements were made with the participants lying semi-recumbent having rested in this position for at least 10 minutes before the initial reading.', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'DAY -2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'DAY -2 (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'DAY -2 (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'DAY -1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'DAY -1 (2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'DAY -1 (3)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'DAY 1 PRE-DOSE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'DAY 1 PRE-DOSE (2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'DAY 1 PRE-DOSE (3)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'DAY 1 4 H', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'DAY 1 24 H', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Standard semi-recumbent 12-lead ECG was obtained after the participant rested for a minimum of 10 minutes (If questionable abnormality was noted on the ECG, 2 more measurements were allowed to provide an average of 3 measurements). Number of participants with abnormal ECG were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinical Chemistry Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'ALT,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'ALT,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'ALT,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'ALT,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'ALT,DAY 1, 24 H,Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Albumin,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Albumin,DAY 1, 24 H,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Albumin,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'ALP,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'ALP,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'AST,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'AST,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'AST,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'AST,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'AST,DAY 1, 24 H,Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Bicarbonate,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Bicarbonate,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Calcium,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Chloride,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Chloride,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Chloride,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Creatine Kinase,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Creatine Kinase,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Creatinine,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Creatinine,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'GGT,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'GGT,DAY 1, PRE-DOSE,Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'GGT,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Glucose,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Glucose,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Glucose,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Glucose,DAY 1, 24 H,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Glucose,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Glucose,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Lactate Dehydrogenase,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Magnesium,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Phosphorus, inorganic,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Potassium,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Potassium,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Potassium,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Sodium,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Sodium,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Total Bilirubin,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Total Bilirubin,DAY 1, PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Total Bilirubin,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Total Protein,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Total Protein,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Total Protein,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Total Protein,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Triglycerides,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Urea/BUN,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Urea/BUN,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Urea/BUN,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Clinical Chemistry data for parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Bicarbonate, Calcium, Chloride, Creatine Kinase, Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Lactate Dehydrogenase, Magnesium, Phosphorus, Potassium, Total Bilirubin, Sodium, Total protein, triglycerides and urea/BUN was reported. Data for number of participants with abnormal clinical Chemistry data was presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specific time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Hematology Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'Basophils,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Basophils,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Basophils,DAY 1, 24 H,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Basophils,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Eosinophils,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Eosinophils,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Eosinophils,DAY 1, 24 H,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Eosinophils,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Hematocrit,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Hematocrit,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Hematocrit,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Hematocrit,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Hemoglobin,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Hemoglobin,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Hemoglobin,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Hemoglobin,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocytes,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocytes,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocytes,DAY 1, 24 H,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocytes,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocytes,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'MCH,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'MCH,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'MCHC,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'MCHC,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'MCV,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'MCV,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Monocytes,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Monocytes,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Monocytes,DAY 1, 24 H,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Monocytes,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Platelet count,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Platelet count,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Platelet count,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'RBC,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'RBC,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'RBC,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Reticulocytes,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Reticulocytes,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Reticulocytes,DAY 1, PRE-DOSE,Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Total Neutrophils,DAY 1, PRE-DOSE,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Total Neutrophils,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Total Neutrophils,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Total Neutrophils,DAY 1, 24 H,High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Total Neutrophils,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'WBC,DAY 1, PRE-DOSE,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'WBC,DAY 1 ,PRE-DOSE,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'WBC,DAY 1, 24 H,Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'WBC,DAY 1, 24 H,Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Data for abnormal Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red Blood Cell (RBC), Reticulocytes, Total Neutrophils, White Blood Cell (WBC) were reported. Data for number of participants with abnormal Hematology were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specific time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Summary of Urine Osmolality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'DAY -2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '631.8', 'spread': '226.85', 'groupId': 'OG000'}, {'value': '651.6', 'spread': '229.44', 'groupId': 'OG001'}, {'value': '647.1', 'spread': '314.81', 'groupId': 'OG002'}, {'value': '618.3', 'spread': '314.15', 'groupId': 'OG003'}, {'value': '702.2', 'spread': '167.39', 'groupId': 'OG004'}]}]}, {'title': 'DAY 1,PRE-DOSE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '330.5', 'spread': '88.89', 'groupId': 'OG000'}, {'value': '364.4', 'spread': '100.89', 'groupId': 'OG001'}, {'value': '425.0', 'spread': '257.05', 'groupId': 'OG002'}, {'value': '304.3', 'spread': '73.13', 'groupId': 'OG003'}, {'value': '441.8', 'spread': '87.61', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre dose) of each treatment period', 'description': 'Urine sample was collected at screening, Day -2 (18:00h) and Day 1 (7:45h) for determination of urine osmolality which was measured in Millimole per kilogram (mmol/kg).', 'unitOfMeasure': 'mmol/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Mean Creatinine Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': '0-4 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '116.9', 'spread': '43.28', 'groupId': 'OG000'}, {'value': '134.5', 'spread': '38.76', 'groupId': 'OG001'}, {'value': '130.2', 'spread': '44.13', 'groupId': 'OG002'}, {'value': '142.2', 'spread': '66.83', 'groupId': 'OG003'}, {'value': '134.3', 'spread': '61.43', 'groupId': 'OG004'}]}]}, {'title': '4-8 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '111.5', 'spread': '42.94', 'groupId': 'OG000'}, {'value': '129.6', 'spread': '54.27', 'groupId': 'OG001'}, {'value': '122.7', 'spread': '52.45', 'groupId': 'OG002'}, {'value': '102.3', 'spread': '31.01', 'groupId': 'OG003'}, {'value': '134.0', 'spread': '34.48', 'groupId': 'OG004'}]}]}, {'title': '8-12 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '131.3', 'spread': '63.82', 'groupId': 'OG000'}, {'value': '123.3', 'spread': '52.40', 'groupId': 'OG001'}, {'value': '105.6', 'spread': '37.92', 'groupId': 'OG002'}, {'value': '140.6', 'spread': '54.35', 'groupId': 'OG003'}, {'value': '120.4', 'spread': '43.29', 'groupId': 'OG004'}]}]}, {'title': '12-16 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '120.8', 'spread': '49.47', 'groupId': 'OG000'}, {'value': '117.9', 'spread': '66.22', 'groupId': 'OG001'}, {'value': '125.3', 'spread': '78.45', 'groupId': 'OG002'}, {'value': '89.5', 'spread': '50.43', 'groupId': 'OG003'}, {'value': '117.8', 'spread': '61.66', 'groupId': 'OG004'}]}]}, {'title': '16-24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '100.5', 'spread': '40.47', 'groupId': 'OG000'}, {'value': '119.5', 'spread': '62.30', 'groupId': 'OG001'}, {'value': '120.8', 'spread': '33.73', 'groupId': 'OG002'}, {'value': '126.4', 'spread': '64.91', 'groupId': 'OG003'}, {'value': '120.0', 'spread': '33.91', 'groupId': 'OG004'}]}]}, {'title': '0-12 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '119.9', 'spread': '34.08', 'groupId': 'OG000'}, {'value': '129.1', 'spread': '28.34', 'groupId': 'OG001'}, {'value': '119.5', 'spread': '28.74', 'groupId': 'OG002'}, {'value': '128.4', 'spread': '37.85', 'groupId': 'OG003'}, {'value': '132.7', 'spread': '24.28', 'groupId': 'OG004'}]}]}, {'title': '0-24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '113.6', 'spread': '30.30', 'groupId': 'OG000'}, {'value': '124.0', 'spread': '35.48', 'groupId': 'OG001'}, {'value': '120.9', 'spread': '30.05', 'groupId': 'OG002'}, {'value': '121.3', 'spread': '38.01', 'groupId': 'OG003'}, {'value': '128.2', 'spread': '26.45', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours post dose of each treatment period.', 'description': 'Creatinine clearance was calculated and reported in Milliliters per minute (mL/min) on Day 1 of each period for each collection interval 0-4, 4-8, 8-12, 12-16 and 16-24 hour, as well as the combined intervals of 0-12 and 0-24 hour. For urine measurements, participants were instructed to void within 30 minutes before administration of study medication.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Summary of Fluid Balance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'Total Fluid Intake,0-4h', 'categories': [{'measurements': [{'value': '1240.0', 'spread': '372.32', 'groupId': 'OG000'}, {'value': '1274.4', 'spread': '407.31', 'groupId': 'OG001'}, {'value': '1221.0', 'spread': '278.07', 'groupId': 'OG002'}, {'value': '1009.5', 'spread': '155.64', 'groupId': 'OG003'}, {'value': '1201.0', 'spread': '355.73', 'groupId': 'OG004'}]}]}, {'title': 'Total Fluid Intake,0-24h', 'categories': [{'measurements': [{'value': '4196.3', 'spread': '1399.83', 'groupId': 'OG000'}, {'value': '4210.0', 'spread': '1034.02', 'groupId': 'OG001'}, {'value': '3934.7', 'spread': '762.13', 'groupId': 'OG002'}, {'value': '4164.4', 'spread': '853.18', 'groupId': 'OG003'}, {'value': '3998.2', 'spread': '1110.77', 'groupId': 'OG004'}]}]}, {'title': 'Total urine output,0-4h', 'categories': [{'measurements': [{'value': '1031.0', 'spread': '277.04', 'groupId': 'OG000'}, {'value': '1107.0', 'spread': '294.54', 'groupId': 'OG001'}, {'value': '1670.5', 'spread': '451.39', 'groupId': 'OG002'}, {'value': '1546.5', 'spread': '593.86', 'groupId': 'OG003'}, {'value': '1212.0', 'spread': '424.94', 'groupId': 'OG004'}]}]}, {'title': 'Total urine output,0-24h', 'categories': [{'measurements': [{'value': '4669.0', 'spread': '757.00', 'groupId': 'OG000'}, {'value': '4421.0', 'spread': '741.14', 'groupId': 'OG001'}, {'value': '5168.0', 'spread': '1212.52', 'groupId': 'OG002'}, {'value': '5004.0', 'spread': '884.00', 'groupId': 'OG003'}, {'value': '4941.0', 'spread': '962.68', 'groupId': 'OG004'}]}]}, {'title': 'Fluid Balance,0-4h', 'categories': [{'measurements': [{'value': '209.0', 'spread': '352.43', 'groupId': 'OG000'}, {'value': '167.4', 'spread': '468.47', 'groupId': 'OG001'}, {'value': '-449.5', 'spread': '533.77', 'groupId': 'OG002'}, {'value': '-537.0', 'spread': '607.98', 'groupId': 'OG003'}, {'value': '-11.0', 'spread': '541.71', 'groupId': 'OG004'}]}]}, {'title': 'Fluid Balance,0-24h', 'categories': [{'measurements': [{'value': '-472.7', 'spread': '1076.26', 'groupId': 'OG000'}, {'value': '-211.0', 'spread': '984.94', 'groupId': 'OG001'}, {'value': '-1233.3', 'spread': '841.19', 'groupId': 'OG002'}, {'value': '-839.6', 'spread': '772.69', 'groupId': 'OG003'}, {'value': '-942.8', 'spread': '513.29', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours post dose of each treatment period.', 'description': 'On Day 1, fluid intake, urine volume and number of micturations were recorded over the intervals for each of the following dosing periods: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. From these measures, fluid balance was calculated over the 24-hour period. Fluid Balance=total fluid intake minus total urine volume. The 0-24h amounts of total Fluid Intake, total urine output, and fluid balance were calculated by adding the amounts collected during these time intervals.', 'unitOfMeasure': 'Milliliters (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'PRIMARY', 'title': 'Mean of Derived Plasma Glucose Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'Pre-Dose', 'categories': [{'measurements': [{'value': '5.75639', 'spread': '1.285496', 'groupId': 'OG000'}, {'value': '6.65953', 'spread': '1.165222', 'groupId': 'OG001'}, {'value': '6.18659', 'spread': '1.696588', 'groupId': 'OG002'}, {'value': '5.72419', 'spread': '0.850452', 'groupId': 'OG003'}, {'value': '5.86796', 'spread': '0.881584', 'groupId': 'OG004'}]}]}, {'title': '2 h', 'categories': [{'measurements': [{'value': '18.26279', 'spread': '2.222558', 'groupId': 'OG000'}, {'value': '13.70542', 'spread': '4.831705', 'groupId': 'OG001'}, {'value': '16.11455', 'spread': '3.711572', 'groupId': 'OG002'}, {'value': '14.76566', 'spread': '2.542980', 'groupId': 'OG003'}, {'value': '15.00435', 'spread': '3.158931', 'groupId': 'OG004'}]}]}, {'title': '4 h', 'categories': [{'measurements': [{'value': '15.31521', 'spread': '3.646185', 'groupId': 'OG000'}, {'value': '9.47778', 'spread': '4.288005', 'groupId': 'OG001'}, {'value': '11.52943', 'spread': '3.154919', 'groupId': 'OG002'}, {'value': '10.68068', 'spread': '3.161241', 'groupId': 'OG003'}, {'value': '11.04094', 'spread': '3.184558', 'groupId': 'OG004'}]}]}, {'title': '6 h', 'categories': [{'measurements': [{'value': '19.53952', 'spread': '4.101401', 'groupId': 'OG000'}, {'value': '9.91464', 'spread': '3.978186', 'groupId': 'OG001'}, {'value': '16.02019', 'spread': '4.685123', 'groupId': 'OG002'}, {'value': '14.97660', 'spread': '5.647356', 'groupId': 'OG003'}, {'value': '15.50949', 'spread': '4.792842', 'groupId': 'OG004'}]}]}, {'title': '8 h', 'categories': [{'measurements': [{'value': '18.01300', 'spread': '5.158167', 'groupId': 'OG000'}, {'value': '8.87790', 'spread': '2.958162', 'groupId': 'OG001'}, {'value': '14.21611', 'spread': '5.359803', 'groupId': 'OG002'}, {'value': '13.69432', 'spread': '6.375146', 'groupId': 'OG003'}, {'value': '14.47146', 'spread': '5.477677', 'groupId': 'OG004'}]}]}, {'title': '12 h', 'categories': [{'measurements': [{'value': '14.67129', 'spread': '6.061024', 'groupId': 'OG000'}, {'value': '11.34791', 'spread': '3.897886', 'groupId': 'OG001'}, {'value': '12.95048', 'spread': '4.566692', 'groupId': 'OG002'}, {'value': '11.31849', 'spread': '3.376891', 'groupId': 'OG003'}, {'value': '11.87914', 'spread': '4.053962', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours post dose of each treatment period.', 'description': 'The plasma measurements at specified time points on Day 1 were collected. Derived plasma glucose parameters were presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'SECONDARY', 'title': 'Incremental Adjusted Weighted Means of Plasma Glucose AUC(0-4) and AUC(0-10) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'AUC(0-4)', 'categories': [{'measurements': [{'value': '8.739', 'spread': '2.4304', 'groupId': 'OG000'}, {'value': '4.480', 'spread': '2.9942', 'groupId': 'OG001'}, {'value': '6.632', 'spread': '2.0126', 'groupId': 'OG002'}, {'value': '6.044', 'spread': '1.9444', 'groupId': 'OG003'}, {'value': '6.099', 'spread': '2.3135', 'groupId': 'OG004'}]}]}, {'title': 'AUC(0-10)', 'categories': [{'measurements': [{'value': '10.535', 'spread': '3.8388', 'groupId': 'OG000'}, {'value': '3.127', 'spread': '2.2467', 'groupId': 'OG001'}, {'value': '7.112', 'spread': '3.3103', 'groupId': 'OG002'}, {'value': '6.653', 'spread': '3.2809', 'groupId': 'OG003'}, {'value': '7.054', 'spread': '3.5440', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.728', 'ciLowerLimit': '-4.219', 'ciUpperLimit': '-1.236', 'groupDescription': 'Difference from placebo to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.325', 'ciLowerLimit': '-3.735', 'ciUpperLimit': '-0.916', 'groupDescription': 'Difference from placebo toGSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.402', 'ciLowerLimit': '-3.862', 'ciUpperLimit': '-0.942', 'groupDescription': 'Difference from placebo to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0382', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.556', 'ciLowerLimit': '0.090', 'ciUpperLimit': '3.021', 'groupDescription': 'Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0132', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.958', 'ciLowerLimit': '0.439', 'ciUpperLimit': '3.477', 'groupDescription': 'Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0161', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.881', 'ciLowerLimit': '0.373', 'ciUpperLimit': '3.389', 'groupDescription': 'Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.592', 'ciLowerLimit': '-5.162', 'ciUpperLimit': '-2.022', 'groupDescription': 'Difference from placebo to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0000', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.820', 'ciLowerLimit': '-5.304', 'ciUpperLimit': '-2.337', 'groupDescription': 'Difference from placebo to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.887', 'ciLowerLimit': '-4.424', 'ciUpperLimit': '-1.350', 'groupDescription': 'Difference from placebo to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.953', 'ciLowerLimit': '1.411', 'ciUpperLimit': '4.496', 'groupDescription': 'Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0015', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.725', 'ciLowerLimit': '1.126', 'ciUpperLimit': '4.324', 'groupDescription': 'Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.659', 'ciLowerLimit': '2.071', 'ciUpperLimit': '5.246', 'groupDescription': 'Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours post dose of each treatment period.', 'description': 'AUC(0-10) was the plasma glucose weighted mean AUC for 0 to 10 h post-dosing and AUC(0-4) was the plasma glucose weighted mean AUC for 0 to 4 h post-dosing. Incremental Adjusted Weighted Means were presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Urinary Glucose Excretion (UGE) for Timed Subintervals up to 24 Hours Post Dose (0-24 H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '324.849', 'spread': '252.6604', 'groupId': 'OG000'}, {'value': '135.119', 'spread': '191.6857', 'groupId': 'OG001'}, {'value': '579.060', 'spread': '227.9230', 'groupId': 'OG002'}, {'value': '601.879', 'spread': '206.4860', 'groupId': 'OG003'}, {'value': '770.249', 'spread': '245.1817', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours post dose of each treatment period', 'description': 'UGE was assessed for timed subintervals up to 24h post-dose. Urine samples were collected at intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h on study days. The 0-24h amounts excreted in urine were calculated by adding the amounts collected during these time intervals.', 'unitOfMeasure': 'mmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Percent of Filtered Glucose in the Urine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': '0-4 H', 'categories': [{'measurements': [{'value': '10.8661', 'spread': '6.21239', 'groupId': 'OG000'}, {'value': '6.5576', 'spread': '5.24295', 'groupId': 'OG001'}, {'value': '40.4788', 'spread': '7.00049', 'groupId': 'OG002'}, {'value': '41.5290', 'spread': '14.95891', 'groupId': 'OG003'}, {'value': '41.3449', 'spread': '12.49532', 'groupId': 'OG004'}]}]}, {'title': '0-12 H', 'categories': [{'measurements': [{'value': '16.7543', 'spread': '9.04186', 'groupId': 'OG000'}, {'value': '7.0663', 'spread': '8.62344', 'groupId': 'OG001'}, {'value': '42.3900', 'spread': '5.75325', 'groupId': 'OG002'}, {'value': '47.5648', 'spread': '10.41524', 'groupId': 'OG003'}, {'value': '47.8442', 'spread': '12.01952', 'groupId': 'OG004'}]}]}, {'title': '0-24 H', 'categories': [{'measurements': [{'value': '11.1012', 'spread': '5.76206', 'groupId': 'OG000'}, {'value': '5.6518', 'spread': '5.12934', 'groupId': 'OG001'}, {'value': '25.4355', 'spread': '4.74207', 'groupId': 'OG002'}, {'value': '29.9386', 'spread': '5.99518', 'groupId': 'OG003'}, {'value': '34.5245', 'spread': '10.00663', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours post dose of each treatment period.', 'description': 'Filtered glucose in the urine was assessed at indicated time points and was presented as Percentage. The 0-12h and 0-24h amounts Percent of filtered glucose in the urine were calculated by adding the amounts collected during these time intervals.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Mean Total Urine Volume 0-24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '4628.5', 'spread': '746.74', 'groupId': 'OG000'}, {'value': '4623.0', 'spread': '828.93', 'groupId': 'OG001'}, {'value': '5267.5', 'spread': '1077.76', 'groupId': 'OG002'}, {'value': '4962.0', 'spread': '885.86', 'groupId': 'OG003'}, {'value': '5274.4', 'spread': '899.07', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Urine volume was recorded over intervals : 0-4h, 4-8h, 8-12h, 12-16h and 16- 24h on Day 1 for each dosing period. Mean total Urine volume over 24 hours was presented.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Mean Creatinine Clearance 0-24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'Placebo+ Prandial Insulin', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG003', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG004', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '113.6', 'spread': '30.30', 'groupId': 'OG000'}, {'value': '124.0', 'spread': '35.48', 'groupId': 'OG001'}, {'value': '120.9', 'spread': '30.05', 'groupId': 'OG002'}, {'value': '121.3', 'spread': '38.01', 'groupId': 'OG003'}, {'value': '128.2', 'spread': '26.45', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Urine samples for calculating creatinine clearance were obtained over the intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. Mean creatinine clearance over 0-24 H was presented.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration vs. Time Curve (AUC) From Time Zero (Time of Dosing) to the Last Time Point With Measurable Analyte Concentration, AUC(0-last), AUC From Time Zero to Infinite Time, AUC(0-inf) of GSK189075 Over Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'AUC(0-inf)', 'categories': [{'measurements': [{'value': '8.101', 'spread': '24', 'groupId': 'OG000'}, {'value': '25.922', 'spread': '38', 'groupId': 'OG001'}, {'value': '58.362', 'spread': '60', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-last)', 'categories': [{'measurements': [{'value': '3.966', 'spread': '95', 'groupId': 'OG000'}, {'value': '16.552', 'spread': '57', 'groupId': 'OG001'}, {'value': '47.390', 'spread': '67', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'AUC(0-last) was defined as area under the plasma concentration vs. time curve from time zero (time of dosing) to the last time point with measurable analyte concentration and AUC(0-inf) was defined as area under the plasma concentration vs. time curve from time zero to infinite time. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period.', 'unitOfMeasure': 'hour*nanograms per milliliter (hr*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of GSK189075 Over Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.266', 'spread': '90', 'groupId': 'OG000'}, {'value': '11.903', 'spread': '92', 'groupId': 'OG001'}, {'value': '39.029', 'spread': '128', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as Geometric Means with respective Geometric Coefficient of Variation (% CV).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Observed Plasma Concentration (Tmax) and Terminal Half Life, (T1/2) of GSK189075 Over Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'title': 'Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.446', 'spread': '68', 'groupId': 'OG000'}, {'value': '0.521', 'spread': '81', 'groupId': 'OG001'}, {'value': '1.054', 'spread': '145', 'groupId': 'OG002'}]}]}, {'title': 't1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.915', 'spread': '20', 'groupId': 'OG000'}, {'value': '1.019', 'spread': '41', 'groupId': 'OG001'}, {'value': '0.678', 'spread': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'Tmax was defined as the time to the maximum or "peak" concentration of a drug observed after multiple administration. T1/2 was defined as the time to when half of the total amount of a particular substance is eliminated from the body. Blood samples obtained during indicated time points. T1/2 was calculated as t1/2 = ln2/λz, with λz (the terminal elimination rate-constant) estimated from log-linear regression analysis of the terminal phase of the plasma concentration-time profile.Tmax and t1/2 values for GSK189075 were presented.', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'AUC From Time Zero to 4 Hours Post Dose, AUC(0-4) for GSK189074 Over Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '243.281', 'spread': '34', 'groupId': 'OG000'}, {'value': '700.970', 'spread': '38', 'groupId': 'OG001'}, {'value': '2038.298', 'spread': '34', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'AUC(0-4) was defined as AUC from time zero to 4 hours post dose. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Oral Clearance (CL/F) Over Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '2849.947', 'spread': '36', 'groupId': 'OG000'}, {'value': '2732.322', 'spread': '41', 'groupId': 'OG001'}, {'value': '2903.590', 'spread': '37', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'Oral clearance is a measure of the rate at which the drug is cleared from the body via metabolism. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK189074 Over Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.436', 'spread': '70', 'groupId': 'OG000'}, {'value': '67.801', 'spread': '36', 'groupId': 'OG001'}, {'value': '74.281', 'spread': '52', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period to obtain the metabolite to parent AUC ratio for GSK189074', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK279782 Over Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK189075 50mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG001', 'title': 'GSK189075 150mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}, {'id': 'OG002', 'title': 'GSK189075 500mg', 'description': 'Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.427', 'spread': '58', 'groupId': 'OG000'}, {'value': '0.442', 'spread': '60', 'groupId': 'OG001'}, {'value': '0.433', 'spread': '55', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period to obtain the metabolite to parent AUC ratio for GSK279782', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Parameter Population comprised of all participants for whom pharmacokinetic parameter estimates were derived during any treatment period'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study Arm', 'description': "Participants received 5 treatments P0, P1, A, B, C in each of the treatment period in a randomized manner separated by a 5 to 35-day washout period between treatments, where Treatment P0 consisted of Basal insulin \\[continuous subcutaneous insulin injection (CSII)\\], mealtime placebo injection, and placebo tablet. Treatment P1 consisted of CSII, mealtime bolus insulin injection, and Placebo tablet. Treatment A consisted of CSII, mealtime placebo injection, GSK189075 50 milligram (mg) tablet. Treatment B consisted of CSII, mealtime placebo injection, GSK189075 150 mg tablet. Treatment C consisted of CSII, mealtime placebo injection, GSK189075 500 mg tablet. The two placebo sessions (P0 and P1) were designed to provide information about the relative efficacy of GSK189075 versus each individual participant's usual mealtime insulin bolus. The number of tablets administered will be same for each treatment arm."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 10 participants with type 1 diabetes mellitus (T1DM) were randomized in this study. Study was conducted between 31 Mach 2008 to 19 January 2009 at a single center in the United States (US).', 'preAssignmentDetails': 'Participants were screened within 28 days of the first dose and a total of 10 participants were randomized to receive the study drug. The participants were admitted on Day -2 and were analyzed of all Baseline safety and glucose control on Day -1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Arm', 'description': "Participants received 5 treatments P0, P1, A, B, C in each of the treatment period in a randomized manner separated by a 5 to 35-day washout period between treatments, where Treatment P0 consisted of Basal insulin \\[continuous subcutaneous insulin injection (CSII)\\], mealtime placebo injection, and placebo tablet. Treatment P1 consisted of CSII, mealtime bolus insulin injection, and Placebo tablet. Treatment A consisted of CSII, mealtime placebo injection, GSK189075 50 mg tablet. Treatment B consisted of CSII, mealtime placebo injection, GSK189075 150 mg tablet. Treatment C consisted of CSII, mealtime placebo injection, GSK189075 500 mg tablet. The two placebo sessions (P0 and P1) were designed to provide information about the relative efficacy of GSK189075 versus each individual participant's usual mealtime insulin bolus. The number of tablets administered will be same for each treatment arm."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '8.08', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'dispFirstSubmitDate': '2012-03-29', 'completionDateStruct': {'date': '2008-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2007-12-14', 'dispFirstSubmitQcDate': '2013-05-13', 'resultsFirstSubmitDate': '2017-08-01', 'studyFirstSubmitQcDate': '2007-12-14', 'dispFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-08', 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE)', 'timeFrame': 'Up to 6 months', 'description': 'Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.'}, {'measure': 'Number of Participants With Hypoglycemia Episodes/Events', 'timeFrame': 'Day 1 of each treatment period', 'description': 'A hypoglycemic event was defined as symptoms of hypoglycemia confirmed by a blood glucose value below normal limits \\[less than 3.89 millimoles per liter (mmol/L)\\] or 70 milligrams per deciliter (mg/dL). Symptoms of hypoglycemia without confirmed blood glucose values were reported as AEs instead of hypoglycemic events. Number of participants with hypoglycemic events were reported.'}, {'measure': 'Change From Baseline Vital Signs: Systolic and Diastolic Blood Pressure (SBP and DBP)', 'timeFrame': 'Day 1 of each treatment period', 'description': 'SBP and DBP were obtained during each treatment period at the indicated time points. Measurements were made with the participant lying semi-recumbent having rested in this position for at least 10 minute before the initial reading.'}, {'measure': 'Change From Baseline Vital Signs: Heart Rate', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Heart rate was obtained during each treatment period at indicated time points. Measurements were made with the participants lying semi-recumbent having rested in this position for at least 10 minutes before the initial reading.'}, {'measure': 'Number of Participants With Abnormal Electrocardiogram (ECG) Findings', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Standard semi-recumbent 12-lead ECG was obtained after the participant rested for a minimum of 10 minutes (If questionable abnormality was noted on the ECG, 2 more measurements were allowed to provide an average of 3 measurements). Number of participants with abnormal ECG were reported.'}, {'measure': 'Number of Participants With Abnormal Clinical Chemistry Data', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Clinical Chemistry data for parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Bicarbonate, Calcium, Chloride, Creatine Kinase, Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Lactate Dehydrogenase, Magnesium, Phosphorus, Potassium, Total Bilirubin, Sodium, Total protein, triglycerides and urea/BUN was reported. Data for number of participants with abnormal clinical Chemistry data was presented.'}, {'measure': 'Number of Participants With Abnormal Hematology Data', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Data for abnormal Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red Blood Cell (RBC), Reticulocytes, Total Neutrophils, White Blood Cell (WBC) were reported. Data for number of participants with abnormal Hematology were reported.'}, {'measure': 'Summary of Urine Osmolality', 'timeFrame': 'Day 1 (pre dose) of each treatment period', 'description': 'Urine sample was collected at screening, Day -2 (18:00h) and Day 1 (7:45h) for determination of urine osmolality which was measured in Millimole per kilogram (mmol/kg).'}, {'measure': 'Mean Creatinine Clearance', 'timeFrame': 'Up to 24 hours post dose of each treatment period.', 'description': 'Creatinine clearance was calculated and reported in Milliliters per minute (mL/min) on Day 1 of each period for each collection interval 0-4, 4-8, 8-12, 12-16 and 16-24 hour, as well as the combined intervals of 0-12 and 0-24 hour. For urine measurements, participants were instructed to void within 30 minutes before administration of study medication.'}, {'measure': 'Summary of Fluid Balance', 'timeFrame': 'Up to 24 hours post dose of each treatment period.', 'description': 'On Day 1, fluid intake, urine volume and number of micturations were recorded over the intervals for each of the following dosing periods: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. From these measures, fluid balance was calculated over the 24-hour period. Fluid Balance=total fluid intake minus total urine volume. The 0-24h amounts of total Fluid Intake, total urine output, and fluid balance were calculated by adding the amounts collected during these time intervals.'}, {'measure': 'Mean of Derived Plasma Glucose Parameters', 'timeFrame': 'Up to 24 hours post dose of each treatment period.', 'description': 'The plasma measurements at specified time points on Day 1 were collected. Derived plasma glucose parameters were presented.'}], 'secondaryOutcomes': [{'measure': 'Incremental Adjusted Weighted Means of Plasma Glucose AUC(0-4) and AUC(0-10) on Day 1', 'timeFrame': 'Up to 24 hours post dose of each treatment period.', 'description': 'AUC(0-10) was the plasma glucose weighted mean AUC for 0 to 10 h post-dosing and AUC(0-4) was the plasma glucose weighted mean AUC for 0 to 4 h post-dosing. Incremental Adjusted Weighted Means were presented.'}, {'measure': 'Urinary Glucose Excretion (UGE) for Timed Subintervals up to 24 Hours Post Dose (0-24 H)', 'timeFrame': 'Up to 24 hours post dose of each treatment period', 'description': 'UGE was assessed for timed subintervals up to 24h post-dose. Urine samples were collected at intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h on study days. The 0-24h amounts excreted in urine were calculated by adding the amounts collected during these time intervals.'}, {'measure': 'Percent of Filtered Glucose in the Urine.', 'timeFrame': 'Up to 24 hours post dose of each treatment period.', 'description': 'Filtered glucose in the urine was assessed at indicated time points and was presented as Percentage. The 0-12h and 0-24h amounts Percent of filtered glucose in the urine were calculated by adding the amounts collected during these time intervals.'}, {'measure': 'Mean Total Urine Volume 0-24 H', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Urine volume was recorded over intervals : 0-4h, 4-8h, 8-12h, 12-16h and 16- 24h on Day 1 for each dosing period. Mean total Urine volume over 24 hours was presented.'}, {'measure': 'Mean Creatinine Clearance 0-24 H', 'timeFrame': 'Day 1 of each treatment period', 'description': 'Urine samples for calculating creatinine clearance were obtained over the intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. Mean creatinine clearance over 0-24 H was presented.'}, {'measure': 'Area Under the Plasma Concentration vs. Time Curve (AUC) From Time Zero (Time of Dosing) to the Last Time Point With Measurable Analyte Concentration, AUC(0-last), AUC From Time Zero to Infinite Time, AUC(0-inf) of GSK189075 Over Period', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'AUC(0-last) was defined as area under the plasma concentration vs. time curve from time zero (time of dosing) to the last time point with measurable analyte concentration and AUC(0-inf) was defined as area under the plasma concentration vs. time curve from time zero to infinite time. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of GSK189075 Over Period', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as Geometric Means with respective Geometric Coefficient of Variation (% CV).'}, {'measure': 'Time to Maximum Observed Plasma Concentration (Tmax) and Terminal Half Life, (T1/2) of GSK189075 Over Period', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'Tmax was defined as the time to the maximum or "peak" concentration of a drug observed after multiple administration. T1/2 was defined as the time to when half of the total amount of a particular substance is eliminated from the body. Blood samples obtained during indicated time points. T1/2 was calculated as t1/2 = ln2/λz, with λz (the terminal elimination rate-constant) estimated from log-linear regression analysis of the terminal phase of the plasma concentration-time profile.Tmax and t1/2 values for GSK189075 were presented.'}, {'measure': 'AUC From Time Zero to 4 Hours Post Dose, AUC(0-4) for GSK189074 Over Period', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'AUC(0-4) was defined as AUC from time zero to 4 hours post dose. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period.'}, {'measure': 'Oral Clearance (CL/F) Over Period', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'Oral clearance is a measure of the rate at which the drug is cleared from the body via metabolism. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period'}, {'measure': 'The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK189074 Over Period', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period to obtain the metabolite to parent AUC ratio for GSK189074'}, {'measure': 'The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK279782 Over Period', 'timeFrame': 'Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period', 'description': 'Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period to obtain the metabolite to parent AUC ratio for GSK279782'}]}, 'conditionsModule': {'keywords': ['type 1 Diabetes mellitus, pharmacokinetics,', 'pharmacodynamics', 'Adult male and females,'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '23011728', 'type': 'DERIVED', 'citation': "Mudaliar S, Armstrong DA, Mavian AA, O'Connor-Semmes R, Mydlow PK, Ye J, Hussey EK, Nunez DJ, Henry RR, Dobbins RL. Remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2, improves serum glucose profiles in type 1 diabetes. Diabetes Care. 2012 Nov;35(11):2198-200. doi: 10.2337/dc12-0508. Epub 2012 Sep 25."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to look at concentrations of GSK189075 in blood when single doses of the drug are taken by mouth in combination with basal insulin. The clinical effects of the drug in combination with insulin on the body will also be studied. The results will help determine doses of GSK189075 can be studied in the future in the type I diabetes mellitus population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male/female, 18 to 55 years old\n* Diagnosis of type 1 diabetes mellitus for at least 6 months; and using a continuous insulin pump\n* Willing and able to follow all study-related instructions provided by the site staff.\n* Willing to provide signed informed consent.\n\nExclusion Criteria:\n\n* Pregnant or a nursing female.\n* Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.\n* Have HIV or hepatitis, or have alcohol or drugs in your system at the screening visit.\n* Have a history of alcohol abuse or have an eating disorder\n* Have been in another research study in the last month or have taken certain medications in the 1 week before study drug would be taken.'}, 'identificationModule': {'nctId': 'NCT00575159', 'briefTitle': 'A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Double-blind, Randomized, Single Ascending Dose Escalation, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK189075 Administered to Subjects With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'KGI107465'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm a', 'description': 'GSK189075', 'interventionNames': ['Drug: GSK189075']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm b', 'description': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'GSK189075', 'type': 'DRUG', 'description': 'investigational drug', 'armGroupLabels': ['Arm a']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['GSK189075'], 'description': 'placebo comparator', 'armGroupLabels': ['Arm b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}