Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-26 @ 6:36 AM
Study NCT ID:
NCT00372957
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2006-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine 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': 'AEs and SAEs were collected up to post-study screen (Follow-up [7 days after the last dose of study medication]).', 'description': 'Safety Population was used for the analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Standard Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Drug Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '238.166', 'groupId': 'OG000', 'lowerLimit': '183.730', 'upperLimit': '308.731'}, {'value': '419.937', 'groupId': 'OG001', 'lowerLimit': '358.461', 'upperLimit': '491.957'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '262.523', 'groupId': 'OG000', 'lowerLimit': '209.416', 'upperLimit': '329.097'}, {'value': '534.888', 'groupId': 'OG001', 'lowerLimit': '486.074', 'upperLimit': '588.604'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hours [hr]), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. Cmax was determined from plasma concentration-time data, using standard model independent methods.', 'unitOfMeasure': 'Nanograms per milliliter (ng/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Population comprised of all participants who received an active dose of GW823093C and for whom PK data was collected.'}, {'type': 'PRIMARY', 'title': 'Standard PK Parameter: Time at Which Cmax Was Observed (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'Tmax, Day 1', 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '3.50', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '6.0'}]}]}, {'title': 'Tmax, Day 7', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. Tmax was determined from plasma concentration-time data, using standard model independent methods.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Standard PK Parameter: Half Life of Terminal Elimination Phase (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '6.662', 'groupId': 'OG000', 'lowerLimit': '5.884', 'upperLimit': '7.543'}, {'value': '8.788', 'groupId': 'OG001', 'lowerLimit': '8.094', 'upperLimit': '9.541'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '7.127', 'groupId': 'OG000', 'lowerLimit': '6.372', 'upperLimit': '7.971'}, {'value': '9.648', 'groupId': 'OG001', 'lowerLimit': '8.674', 'upperLimit': '10.731'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. T1/2 was determined from plasma concentration-time data, using standard model independent methods.', 'unitOfMeasure': 'Hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Standard PK Parameter: Area Under the Plasma Drug Concentration Versus Time Curve Extrapolated to Infinity (AUC[0-inf]), AUC From 0 to the Last Measurable Concentration (AUC[0-t])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'AUC(0-t), Day 1', 'categories': [{'measurements': [{'value': '2261.076', 'groupId': 'OG000', 'lowerLimit': '1944.959', 'upperLimit': '2628.572'}, {'value': '4800.677', 'groupId': 'OG001', 'lowerLimit': '4451.224', 'upperLimit': '5177.565'}]}]}, {'title': 'AUC(0-t), Day 7', 'categories': [{'measurements': [{'value': '2545.651', 'groupId': 'OG000', 'lowerLimit': '2155.396', 'upperLimit': '3006.567'}, {'value': '6129.987', 'groupId': 'OG001', 'lowerLimit': '5801.218', 'upperLimit': '6477.387'}]}]}, {'title': 'AUC(0-inf), Day 1', 'categories': [{'measurements': [{'value': '2508.608', 'groupId': 'OG000', 'lowerLimit': '2114.506', 'upperLimit': '2976.163'}, {'value': '5786.001', 'groupId': 'OG001', 'lowerLimit': '5449.326', 'upperLimit': '6143.477'}]}]}, {'title': 'AUC(0-inf), Day 7', 'categories': [{'measurements': [{'value': '2870.716', 'groupId': 'OG000', 'lowerLimit': '2374.654', 'upperLimit': '3470.405'}, {'value': '7562.008', 'groupId': 'OG001', 'lowerLimit': '7132.565', 'upperLimit': '8017.307'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. AUC\\[0-inf\\] and AUC\\[0-t\\] was determined from plasma concentration-time data, using standard model independent methods.', 'unitOfMeasure': 'Hr.ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Standard PK Parameter: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '9.029', 'groupId': 'OG000', 'lowerLimit': '6.625', 'upperLimit': '12.305'}, {'value': '16.645', 'groupId': 'OG001', 'lowerLimit': '14.331', 'upperLimit': '19.333'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '10.704', 'groupId': 'OG000', 'lowerLimit': '8.425', 'upperLimit': '13.601'}, {'value': '18.442', 'groupId': 'OG001', 'lowerLimit': '15.817', 'upperLimit': '21.503'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. %AUCex was determined from plasma concentration-time data, using standard model independent methods.', 'unitOfMeasure': 'Percentage of AUCex', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Standard PK Parameter: Constant Rate of Elimination (lambda_z)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.10403', 'groupId': 'OG000', 'lowerLimit': '0.09188', 'upperLimit': '0.11779'}, {'value': '0.07887', 'groupId': 'OG001', 'lowerLimit': '0.07266', 'upperLimit': '0.08562'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.09727', 'groupId': 'OG000', 'lowerLimit': '0.08697', 'upperLimit': '0.10879'}, {'value': '0.07184', 'groupId': 'OG001', 'lowerLimit': '0.06458', 'upperLimit': '0.07992'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. Lambda\\_z was determined from plasma concentration-time data, using standard model independent methods.', 'unitOfMeasure': '1/hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Standard PK Parameter: Total Clearance (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '5.979', 'groupId': 'OG000', 'lowerLimit': '5.040', 'upperLimit': '7.094'}, {'value': '5.185', 'groupId': 'OG001', 'lowerLimit': '4.883', 'upperLimit': '5.505'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '5.225', 'groupId': 'OG000', 'lowerLimit': '4.322', 'upperLimit': '6.317'}, {'value': '3.967', 'groupId': 'OG001', 'lowerLimit': '3.742', 'upperLimit': '4.206'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. CL/F was determined from plasma concentration-time data, using standard model independent methods.', 'unitOfMeasure': 'Liter per hour (L/hr)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Standard PK Parameter: Apparent Volume of Distribution (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '57.470', 'groupId': 'OG000', 'lowerLimit': '51.466', 'upperLimit': '64.175'}, {'value': '65.735', 'groupId': 'OG001', 'lowerLimit': '58.465', 'upperLimit': '73.910'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '53.724', 'groupId': 'OG000', 'lowerLimit': '48.155', 'upperLimit': '59.938'}, {'value': '55.221', 'groupId': 'OG001', 'lowerLimit': '50.088', 'upperLimit': '60.881'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. Vz/F was determined from plasma concentration-time data, using standard model independent methods.', 'unitOfMeasure': 'L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Standard PK Parameter: R[Cmax], Extent of Accumulation (Ro), Steady State Accumulation Ratio (Rs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'R[Cmax]', 'categories': [{'measurements': [{'value': '1.102', 'groupId': 'OG000', 'lowerLimit': '0.946', 'upperLimit': '1.284'}, {'value': '1.274', 'groupId': 'OG001', 'lowerLimit': '1.110', 'upperLimit': '1.461'}]}]}, {'title': 'Ro', 'categories': [{'measurements': [{'value': '1.126', 'groupId': 'OG000', 'lowerLimit': '1.082', 'upperLimit': '1.171'}, {'value': '1.277', 'groupId': 'OG001', 'lowerLimit': '1.183', 'upperLimit': '1.379'}]}]}, {'title': 'Rs', 'categories': [{'measurements': [{'value': '1.015', 'groupId': 'OG000', 'lowerLimit': '0.987', 'upperLimit': '1.044'}, {'value': '1.059', 'groupId': 'OG001', 'lowerLimit': '0.988', 'upperLimit': '1.136'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. R\\[Cmax\\], Ro and Rs were determined from plasma concentration-time data, using standard model independent methods. R\\[Cmax\\] = Cmax (Day 7)/Cmax (Day 1), Ro = AUC(0-tau) (Day 7)/ AUC(0-tau) (Day 1) and Rs = AUC(0-tau) (Day 7)/ AUC(0-inf) (Day 1).', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Percent Dipeptidyl-peptidase IV (DPP-IV) Inhibition by Dose (Day 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'Pre-dose', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000'}, {'value': '69.565', 'groupId': 'OG001'}, {'value': '88.854', 'groupId': 'OG002'}]}]}, {'title': '0.5hr', 'categories': [{'measurements': [{'value': '2.273', 'groupId': 'OG000'}, {'value': '83.612', 'groupId': 'OG001'}, {'value': '88.854', 'groupId': 'OG002'}]}]}, {'title': '1hr', 'categories': [{'measurements': [{'value': '-1.724', 'groupId': 'OG000'}, {'value': '91.107', 'groupId': 'OG001'}, {'value': '91.033', 'groupId': 'OG002'}]}]}, {'title': '1.5hr', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000'}, {'value': '91.304', 'groupId': 'OG001'}, {'value': '91.033', 'groupId': 'OG002'}]}]}, {'title': '2hr', 'categories': [{'measurements': [{'value': '-1.724', 'groupId': 'OG000'}, {'value': '91.304', 'groupId': 'OG001'}, {'value': '92.593', 'groupId': 'OG002'}]}]}, {'title': '3hr', 'categories': [{'measurements': [{'value': '-2.273', 'groupId': 'OG000'}, {'value': '91.304', 'groupId': 'OG001'}, {'value': '92.593', 'groupId': 'OG002'}]}]}, {'title': '4hr', 'categories': [{'measurements': [{'value': '-3.448', 'groupId': 'OG000'}, {'value': '91.304', 'groupId': 'OG001'}, {'value': '92.593', 'groupId': 'OG002'}]}]}, {'title': '6 hr', 'categories': [{'measurements': [{'value': '-5.721', 'groupId': 'OG000'}, {'value': '91.107', 'groupId': 'OG001'}, {'value': '91.609', 'groupId': 'OG002'}]}]}, {'title': '8 hr', 'categories': [{'measurements': [{'value': '-9.091', 'groupId': 'OG000'}, {'value': '91.107', 'groupId': 'OG001'}, {'value': '92.593', 'groupId': 'OG002'}]}]}, {'title': '12 hr', 'categories': [{'measurements': [{'value': '-9.091', 'groupId': 'OG000'}, {'value': '91.107', 'groupId': 'OG001'}, {'value': '91.033', 'groupId': 'OG002'}]}]}, {'title': '24 hr', 'categories': [{'measurements': [{'value': '-4.105', 'groupId': 'OG000'}, {'value': '68.783', 'groupId': 'OG001'}, {'value': '88.562', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7', 'description': 'For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing ethylenediamine tetraacetic acid (EDTA2K) and centrifuged at approximately 4 degree Celsius, at approximately 2500 revolution per minute (rpm) for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. DPP-IV inhibition was estimated by using the percent change from pre-dose of DPP-IV activity. DPP-IV inhibition was done at pre-dose, 0.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr and 24 hr.', 'unitOfMeasure': 'Percent inhibition', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Parameter Population comprised of all participants who received study medication (active or placebo) and for whom PD data was available.'}, {'type': 'PRIMARY', 'title': 'DPP-IV Activity Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'AUC(0-12 hr), Day -1', 'categories': [{'measurements': [{'value': '2.34', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '2.41', 'spread': '0.70', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-12 hr), Day 7', 'categories': [{'measurements': [{'value': '2.35', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '0.02', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day -1', 'categories': [{'measurements': [{'value': '2.35', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '2.44', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '2.42', 'spread': '0.71', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day 7', 'categories': [{'measurements': [{'value': '2.34', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '0.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.10', 'ciLowerLimit': '-2.28', 'ciUpperLimit': '-1.93', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.16', 'ciLowerLimit': '-2.33', 'ciUpperLimit': '-1.98', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.98', 'ciLowerLimit': '-2.15', 'ciUpperLimit': '-1.82', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.12', 'ciLowerLimit': '-2.28', 'ciUpperLimit': '-1.95', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2K and centrifuged at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis has been presented in analysis. Unit of measure: Nano mole per minute per milliliter (nmol/min/mL).', 'unitOfMeasure': 'nmol/min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Parameter Population comprised of all participants who received study medication (active or placebo) and for whom PD data was available.'}, {'type': 'PRIMARY', 'title': 'Active Glucagon-like Peptide-1 (GLP-1) Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'AUC(0-12 hr), Day -1', 'categories': [{'measurements': [{'value': '4.64', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '3.21', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '5.48', 'spread': '3.04', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-12 hr), Day 7', 'categories': [{'measurements': [{'value': '4.74', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '7.19', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '10.79', 'spread': '3.32', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day -1', 'categories': [{'measurements': [{'value': '4.25', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '4.99', 'spread': '2.64', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day 7', 'categories': [{'measurements': [{'value': '4.65', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '6.37', 'spread': '2.22', 'groupId': 'OG001'}, {'value': '9.81', 'spread': '2.77', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.87', 'ciLowerLimit': '2.33', 'ciUpperLimit': '5.41', 'estimateComment': 'he point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.21', 'ciLowerLimit': '3.70', 'ciUpperLimit': '6.73', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.22', 'ciLowerLimit': '1.90', 'ciUpperLimit': '4.54', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.39', 'ciLowerLimit': '3.10', 'ciUpperLimit': '5.68', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For the analysis of active GLP-1 concentrations, approximately 3 mL of whole blood was collected into a vacuum tube containing DPP-IV inhibitor, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.', 'unitOfMeasure': 'Picomole (pM)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Insulin Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'AUC(0-12 hr), Day -1', 'categories': [{'measurements': [{'value': '17.35', 'spread': '7.37', 'groupId': 'OG000'}, {'value': '17.55', 'spread': '7.72', 'groupId': 'OG001'}, {'value': '21.28', 'spread': '12.06', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-12 hr), Day 7', 'categories': [{'measurements': [{'value': '18.07', 'spread': '9.28', 'groupId': 'OG000'}, {'value': '16.70', 'spread': '6.75', 'groupId': 'OG001'}, {'value': '22.79', 'spread': '11.95', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day -1', 'categories': [{'measurements': [{'value': '16.60', 'spread': '6.75', 'groupId': 'OG000'}, {'value': '17.87', 'spread': '7.68', 'groupId': 'OG001'}, {'value': '21.72', 'spread': '12.66', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day 7', 'categories': [{'measurements': [{'value': '16.89', 'spread': '7.73', 'groupId': 'OG000'}, {'value': '16.64', 'spread': '6.91', 'groupId': 'OG001'}, {'value': '22.81', 'spread': '11.90', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.56', 'ciLowerLimit': '-6.00', 'ciUpperLimit': '2.89', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '-3.30', 'ciUpperLimit': '5.72', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.35', 'ciLowerLimit': '-5.20', 'ciUpperLimit': '2.50', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '-2.47', 'ciUpperLimit': '5.43', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For the analysis of plasma insulin, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.', 'unitOfMeasure': 'Micro units per milliliter (µU/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Glucagon Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'AUC(0-12 hr), Day -1', 'categories': [{'measurements': [{'value': '113.1', 'spread': '49.2', 'groupId': 'OG000'}, {'value': '100.1', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '125.1', 'spread': '37.0', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-12 hr), Day 7', 'categories': [{'measurements': [{'value': '113.9', 'spread': '34.4', 'groupId': 'OG000'}, {'value': '97.3', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '105.6', 'spread': '27.2', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day -1', 'categories': [{'measurements': [{'value': '114.7', 'spread': '53.2', 'groupId': 'OG000'}, {'value': '104.4', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '129.0', 'spread': '41.0', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day 7', 'categories': [{'measurements': [{'value': '113.4', 'spread': '32.5', 'groupId': 'OG000'}, {'value': '97.0', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '105.6', 'spread': '24.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.1', 'ciLowerLimit': '-20.4', 'ciUpperLimit': '4.2', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.2', 'ciLowerLimit': '-28.4', 'ciUpperLimit': '-3.9', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.9', 'ciLowerLimit': '-23.1', 'ciUpperLimit': '1.4', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.6', 'ciLowerLimit': '-27.9', 'ciUpperLimit': '-3.3', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For the analysis of plasma glucagons concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing aprotinin, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.', 'unitOfMeasure': 'Picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Parameter Population.'}, {'type': 'PRIMARY', 'title': 'C-peptide Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'AUC(0-12 hr), Day -1', 'categories': [{'measurements': [{'value': '4.29', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '3.78', 'spread': '1.54', 'groupId': 'OG001'}, {'value': '4.73', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-12 hr), Day 7', 'categories': [{'measurements': [{'value': '4.46', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '5.25', 'spread': '1.83', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day -1', 'categories': [{'measurements': [{'value': '3.88', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '4.40', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day 7', 'categories': [{'measurements': [{'value': '4.01', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '4.07', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '4.94', 'spread': '1.72', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '1.16', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '1.32', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '1.07', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '1.21', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For the analysis of plasma C-peptide concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Parameter Population.'}, {'type': 'PRIMARY', 'title': 'Glucose Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'AUC(0-12 hr), Day -1', 'categories': [{'measurements': [{'value': '218.9', 'spread': '69.5', 'groupId': 'OG000'}, {'value': '233.8', 'spread': '68.7', 'groupId': 'OG001'}, {'value': '227.5', 'spread': '64.1', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-12 hr), Day 7', 'categories': [{'measurements': [{'value': '210.0', 'spread': '73.5', 'groupId': 'OG000'}, {'value': '203.2', 'spread': '52.5', 'groupId': 'OG001'}, {'value': '208.6', 'spread': '62.1', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day -1', 'categories': [{'measurements': [{'value': '211.4', 'spread': '66.0', 'groupId': 'OG000'}, {'value': '221.6', 'spread': '58.2', 'groupId': 'OG001'}, {'value': '219.1', 'spread': '51.6', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-24 hr), Day 7', 'categories': [{'measurements': [{'value': '201.1', 'spread': '67.2', 'groupId': 'OG000'}, {'value': '194.6', 'spread': '45.5', 'groupId': 'OG001'}, {'value': '202.0', 'spread': '55.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.9', 'ciLowerLimit': '-40.7', 'ciUpperLimit': '0.9', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.0', 'ciLowerLimit': '-29.8', 'ciUpperLimit': '11.7', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-12 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.9', 'ciLowerLimit': '-33.2', 'ciUpperLimit': '1.4', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-23.4', 'ciUpperLimit': '11.1', 'estimateComment': 'The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.', 'groupDescription': 'AUC(0-24 hr), Day 7', 'statisticalMethod': 'Double-delta analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For the analysis of plasma glucose concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing sodium fluoride, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.', 'unitOfMeasure': 'Milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Parameter Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'OG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to post-study screen (Follow-up [7 days after the last dose of study medication])', 'description': 'AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is serious corresponding to those listed in above definition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants who received study medication (active or placebo).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 milliliter (mL) of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'FG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 milligrams (mg) of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'FG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted across two centers in Japan from 22 March 2006 to 28 June 2006.', 'preAssignmentDetails': 'A total of 30 participants were randomized in the study. After screening, participants were washed off of diabetes medications for two weeks prior to the first dose of study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'BG001', 'title': 'GW823093C 15 mg', 'description': 'Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'BG002', 'title': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20 to 64 Years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2006-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-30', 'studyFirstSubmitDate': '2006-09-05', 'resultsFirstSubmitDate': '2017-08-18', 'studyFirstSubmitQcDate': '2006-09-05', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-18', 'studyFirstPostDateStruct': {'date': '2006-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Drug Concentration (Cmax)', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hours [hr]), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. Cmax was determined from plasma concentration-time data, using standard model independent methods.'}, {'measure': 'Standard PK Parameter: Time at Which Cmax Was Observed (Tmax)', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. Tmax was determined from plasma concentration-time data, using standard model independent methods.'}, {'measure': 'Standard PK Parameter: Half Life of Terminal Elimination Phase (t1/2)', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. T1/2 was determined from plasma concentration-time data, using standard model independent methods.'}, {'measure': 'Standard PK Parameter: Area Under the Plasma Drug Concentration Versus Time Curve Extrapolated to Infinity (AUC[0-inf]), AUC From 0 to the Last Measurable Concentration (AUC[0-t])', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. AUC\\[0-inf\\] and AUC\\[0-t\\] was determined from plasma concentration-time data, using standard model independent methods.'}, {'measure': 'Standard PK Parameter: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex)', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. %AUCex was determined from plasma concentration-time data, using standard model independent methods.'}, {'measure': 'Standard PK Parameter: Constant Rate of Elimination (lambda_z)', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. Lambda\\_z was determined from plasma concentration-time data, using standard model independent methods.'}, {'measure': 'Standard PK Parameter: Total Clearance (CL/F)', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. CL/F was determined from plasma concentration-time data, using standard model independent methods.'}, {'measure': 'Standard PK Parameter: Apparent Volume of Distribution (Vz/F)', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. Vz/F was determined from plasma concentration-time data, using standard model independent methods.'}, {'measure': 'Standard PK Parameter: R[Cmax], Extent of Accumulation (Ro), Steady State Accumulation Ratio (Rs)', 'timeFrame': 'Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)', 'description': 'PK parameters were calculated using data at the actual time of blood collection. R\\[Cmax\\], Ro and Rs were determined from plasma concentration-time data, using standard model independent methods. R\\[Cmax\\] = Cmax (Day 7)/Cmax (Day 1), Ro = AUC(0-tau) (Day 7)/ AUC(0-tau) (Day 1) and Rs = AUC(0-tau) (Day 7)/ AUC(0-inf) (Day 1).'}, {'measure': 'Percent Dipeptidyl-peptidase IV (DPP-IV) Inhibition by Dose (Day 7)', 'timeFrame': 'Day 7', 'description': 'For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing ethylenediamine tetraacetic acid (EDTA2K) and centrifuged at approximately 4 degree Celsius, at approximately 2500 revolution per minute (rpm) for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. DPP-IV inhibition was estimated by using the percent change from pre-dose of DPP-IV activity. DPP-IV inhibition was done at pre-dose, 0.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr and 24 hr.'}, {'measure': 'DPP-IV Activity Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2K and centrifuged at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis has been presented in analysis. Unit of measure: Nano mole per minute per milliliter (nmol/min/mL).'}, {'measure': 'Active Glucagon-like Peptide-1 (GLP-1) Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For the analysis of active GLP-1 concentrations, approximately 3 mL of whole blood was collected into a vacuum tube containing DPP-IV inhibitor, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.'}, {'measure': 'Insulin Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For the analysis of plasma insulin, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.'}, {'measure': 'Glucagon Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For the analysis of plasma glucagons concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing aprotinin, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.'}, {'measure': 'C-peptide Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For the analysis of plasma C-peptide concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.'}, {'measure': 'Glucose Weighted Mean AUCs at Baseline (Day -1) and Day 7', 'timeFrame': 'Baseline (Day -1) and Day 7', 'description': 'For the analysis of plasma glucose concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing sodium fluoride, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to post-study screen (Follow-up [7 days after the last dose of study medication])', 'description': 'AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is serious corresponding to those listed in above definition.'}]}, 'conditionsModule': {'keywords': ['pharmacodynamics', 'Diabetes', 'pharmacokinetics'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes mellitus (T2DM) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* T2DM diagnosed at least 3 months prior to Screening and fasting plasma glucose (FPG) level \\<280mg/dL at the Screening visit.\n* Concurrent T2DM therapy: Must be diet controlled - OR - not taking more than 2 oral anti-diabetic agents, and willing to withdraw from these treatments 2 weeks prior to the first dosing.\n\nExclusion criteria:\n\n* Must not have any other major illness other than diabetes'}, 'identificationModule': {'nctId': 'NCT00372957', 'briefTitle': 'Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'PK/PD Study of GW823093 in Japanese Subjects With T2DM: A Single-blind, Placebo Controlled, Randomized, Multi-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GW823093C Administered Orally for 7 Days in Japanese Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'DPB106653'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received two capsules of matching placebo orally once daily in the morning with 150 milliliter (mL) of water at least 15 minutes prior to breakfast for 7 Days.', 'interventionNames': ['Drug: GW823093 placebo capsule']}, {'type': 'EXPERIMENTAL', 'label': 'GW823093C 15 mg', 'description': 'Participants received one 15 milligrams (mg) of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.', 'interventionNames': ['Drug: GW823093 15mg', 'Drug: GW823093 placebo capsule']}, {'type': 'EXPERIMENTAL', 'label': 'GW823093C 30 mg', 'description': 'Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.', 'interventionNames': ['Drug: GW823093 30mg']}], 'interventions': [{'name': 'GW823093 15mg', 'type': 'DRUG', 'otherNames': ['GW823093'], 'description': 'White opaque capsule containing 15mg of GW823093 as free base', 'armGroupLabels': ['GW823093C 15 mg']}, {'name': 'GW823093 placebo capsule', 'type': 'DRUG', 'description': 'Matching placebo of GW823093 capsule or 15mg capsule', 'armGroupLabels': ['GW823093C 15 mg', 'Placebo']}, {'name': 'GW823093 30mg', 'type': 'DRUG', 'description': 'White opaque capsule containing 15mg of GW823093 as free base', 'armGroupLabels': ['GW823093C 30 mg']}]}, 'contactsLocationsModule': {'locations': [{'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}