Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02408120
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2015-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'priyathama.vellanki@emory.edu', 'phone': '404-251-8957', 'title': 'Dr. Priyathama Vellanki', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 11, 'seriousNumAtRisk': 108, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 12, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Daily BG Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '172', 'spread': '38.2', 'groupId': 'OG000'}, {'value': '173', 'spread': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Blood Glucose Levels Before Lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'spread': '16', 'groupId': 'OG000'}, {'value': '172', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The blood glucose levels will be assessed prior to lunch using a glucose meter.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Blood Glucose Levels at Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '157', 'spread': '18', 'groupId': 'OG000'}, {'value': '171', 'spread': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The blood glucose levels will be assessed at bedtime using a glucose meter.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Blood Glucose Levels Before Dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '151', 'spread': '19', 'groupId': 'OG000'}, {'value': '160', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The blood glucose levels will be assessed before dinner using a glucose meter.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycemia Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The number of occurrences of hypoglycemia (blood glucose levels \\< 70 mg/dL) will be recorded.', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Hyperglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The number of occurrences of hyperglycemia (blood glucose levels \\> 260 mg/dL) will be recorded.', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Blood Glucose Readings Within 100-140 mg/dL Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded.', 'unitOfMeasure': 'number of readings', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Number of Days of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '7.5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The average number of days in the hospital for subjects will be calculated.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The total number of subject deaths during hospital stay will be recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects That Experienced Hospital Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury \\[rise of serum creatinine \\>0.5 mg/dL (or 50%) of baseline value\\]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Daily Dose of Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'OG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '43', 'groupId': 'OG000'}, {'value': '41', 'spread': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'Daily dose of insulin will be recorded', 'unitOfMeasure': 'units/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'FG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Treatment Refusal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Received Steroids', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Discharged same day', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not receive insulin', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 226 subjects consented from October 2015 to December 2019. Two subjects withdrew or left the hospital prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.'}, {'id': 'BG001', 'title': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-14', 'size': 1754779, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-09T19:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-10', 'studyFirstSubmitDate': '2015-03-27', 'resultsFirstSubmitDate': '2020-12-10', 'studyFirstSubmitQcDate': '2015-03-31', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-10', 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Daily BG Levels', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Mean Blood Glucose Levels Before Lunch', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The blood glucose levels will be assessed prior to lunch using a glucose meter.'}, {'measure': 'Mean Blood Glucose Levels at Bedtime', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The blood glucose levels will be assessed at bedtime using a glucose meter.'}, {'measure': 'Mean Blood Glucose Levels Before Dinner', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The blood glucose levels will be assessed before dinner using a glucose meter.'}, {'measure': 'Number of Hypoglycemia Events', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The number of occurrences of hypoglycemia (blood glucose levels \\< 70 mg/dL) will be recorded.'}, {'measure': 'Incidence of Hyperglycemia', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The number of occurrences of hyperglycemia (blood glucose levels \\> 260 mg/dL) will be recorded.'}, {'measure': 'Number of Blood Glucose Readings Within 100-140 mg/dL Range', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded.'}, {'measure': 'Average Number of Days of Hospital Stay', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The average number of days in the hospital for subjects will be calculated.'}, {'measure': 'Mortality', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The total number of subject deaths during hospital stay will be recorded.'}, {'measure': 'Number of Subjects That Experienced Hospital Complications', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury \\[rise of serum creatinine \\>0.5 mg/dL (or 50%) of baseline value\\]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.'}, {'measure': 'Mean Daily Dose of Insulin', 'timeFrame': '5 days (average time of discharge from the hospital)', 'description': 'Daily dose of insulin will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hyperglycemia', 'Hypoglycemia'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '35675498', 'type': 'DERIVED', 'citation': 'Vellanki P, Cardona S, Galindo RJ, Urrutia MA, Pasquel FJ, Davis GM, Fayfman M, Migdal A, Peng L, Umpierrez GE. Efficacy and Safety of Intensive Versus Nonintensive Supplemental Insulin With a Basal-Bolus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes: A Randomized Clinical Study. Diabetes Care. 2022 Oct 1;45(10):2217-2223. doi: 10.2337/dc21-1606.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.', 'detailedDescription': 'The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. The doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. Many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. It has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. Studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. This study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma\n2. Known history of Type 2 diabetes mellitus for \\>3 months\n3. Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy\n4. Blood glucose levels between \\>140 mg and \\<400 mg/dL without laboratory evidence of diabetic ketoacidosis\n\nExclusion Criteria:\n\n1. Hyperglycemia without a history of diabetes\n2. Subjects with acute critical illness admitted to the ICU or expected to require ICU admission\n3. Subjects receiving continuous insulin infusion\n4. Clinically relevant hepatic disease\n5. Corticosteroid therapy\n6. Serum creatinine ≥ 3.5 mg/dL and/or glomerular filtration rate (GFR) \\<30\n7. Subjects unable to sign consent\n8. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02408120', 'briefTitle': 'Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen', 'orgStudyIdInfo': {'id': 'IRB00078695'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Aspart for BG > 140 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>140 mg/dL.', 'interventionNames': ['Drug: Insulin glargine', 'Drug: Insulin aspart', 'Drug: Supplemental insulin aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Aspart for BG > 260 mg/dL', 'description': 'Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \\>260 mg/dL.', 'interventionNames': ['Drug: Insulin glargine', 'Drug: Insulin aspart', 'Drug: Supplemental insulin aspart']}], 'interventions': [{'name': 'Insulin glargine', 'type': 'DRUG', 'otherNames': ['Lantus (glargine)'], 'description': 'Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day.\n\nDaily insulin dose will be adjusted as follow:\n\n* If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change\n* If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day\n* If the fasting and pre-dinner BG is \\>180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day\n* If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day\n* If a patient develops hypoglycemia (BG \\<70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.', 'armGroupLabels': ['Insulin Aspart for BG > 140 mg/dL', 'Insulin Aspart for BG > 260 mg/dL']}, {'name': 'Insulin aspart', 'type': 'DRUG', 'otherNames': ['Novolog'], 'description': 'Half of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held.\n\nDaily insulin dose will be adjusted as follow:\n\n* If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change\n* If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day\n* If the fasting and pre-dinner BG is \\>180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day\n* If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day\n* If a patient develops hypoglycemia (BG \\<70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.', 'armGroupLabels': ['Insulin Aspart for BG > 140 mg/dL', 'Insulin Aspart for BG > 260 mg/dL']}, {'name': 'Supplemental insulin aspart', 'type': 'DRUG', 'otherNames': ['Novolog'], 'description': 'Insulin aspart will be administered following the supplemental insulin scale protocol.\n\nFor the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows:\n\n* BG \\>141-180 mg/dL; 2-4 units of insulin aspart\n* BG between 181-220 mg/dL; 3-6 units of insulin aspart\n* BG between 221-260 mg/dL; 4-8 units of insulin aspart\n* BG between 261-300 mg/dL; 5-10 units of insulin aspart\n* BG between 301-350 mg/dL; 6-12 units of insulin aspart\n* BG between 351-400 mg/dL; 7-14 units of insulin aspart\n* BG \\> 400 mg/dL; 8-16 units of insulin aspart\n\nFor the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows:\n\n* BG between 261-300 mg/dL; 5-10 units of insulin aspart\n* BG between 301-350 mg/dL; 6-12 units of insulin aspart\n* BG between 351-400 mg/dL; 7-14 units of insulin aspart\n* BG \\> 400 mg/dL; 8-16 units of insulin aspart', 'armGroupLabels': ['Insulin Aspart for BG > 140 mg/dL', 'Insulin Aspart for BG > 260 mg/dL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Priyathama Vellanki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Priyathama Vellanki', 'investigatorAffiliation': 'Emory University'}}}}