Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-30 @ 3:22 PM
Study NCT ID:
NCT00851903
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2009-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D008687', 'term': 'Metformin'}], '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': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'sanofi-aventis'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 45 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed throughout the extension study (12 weeks). Only adverse events starting from inclusion in the extension study were taken into account.', 'eventGroups': [{'id': 'EG000', 'title': 'Combination Insulin Glargine and Sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\<FPG ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food.", 'otherNumAtRisk': 112, 'otherNumAffected': 0, 'seriousNumAtRisk': 112, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Insulin Glargine and Sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\<FPG ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food."}], 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000', 'lowerLimit': '41.97', 'upperLimit': '61.70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'study endpoint: week 12 or earlier in case of premature discontinuation', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed consisted of the subset of mITT patients who had HbA1c value at study endpoint.'}, {'type': 'SECONDARY', 'title': 'HbA1c: Change From Baseline to Study Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Insulin Glargine and Sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\<FPG ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.80', 'spread': '1.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, study endpoint: week 12 or earlier in case of premature discontinuation', 'description': 'Change = study endpoint - baseline', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Insulin Glargine and Sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\<FPG ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food."}], 'classes': [{'categories': [{'measurements': [{'value': '-35.43', 'spread': '39.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, study endpoint: week 12 or week 8 if value not available at week 12', 'description': 'SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).\n\nChange = study endpoint - baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure'}, {'type': 'SECONDARY', 'title': '7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Insulin Glargine and Sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\<FPG ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food."}], 'classes': [{'title': 'Before breakfast (N=104)', 'categories': [{'measurements': [{'value': '-34.2', 'spread': '38.1', 'groupId': 'OG000'}]}]}, {'title': 'After breakfast (N=103)', 'categories': [{'measurements': [{'value': '-34.1', 'spread': '48.1', 'groupId': 'OG000'}]}]}, {'title': 'Before lunch (N=104)', 'categories': [{'measurements': [{'value': '-26.6', 'spread': '48.2', 'groupId': 'OG000'}]}]}, {'title': 'After lunch (N=104)', 'categories': [{'measurements': [{'value': '-26.5', 'spread': '43.7', 'groupId': 'OG000'}]}]}, {'title': 'Before dinner (N=103)', 'categories': [{'measurements': [{'value': '-25.1', 'spread': '43.0', 'groupId': 'OG000'}]}]}, {'title': 'After dinner (N=100)', 'categories': [{'measurements': [{'value': '-24.9', 'spread': '46.7', 'groupId': 'OG000'}]}]}, {'title': 'At bedtime (N=93)', 'categories': [{'measurements': [{'value': '-35.2', 'spread': '51.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, study endpoint: week 12 or week 8 if value not available at week 12', 'description': '7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.\n\nChange = study endpoint - baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.\n\nDepending on the time point, few values were missing.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Insulin Glargine and Sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\<FPG ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 N=110', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 N=110', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 4, week 8, week 12', 'description': 'Daily dose at the face-to-face visits', 'unitOfMeasure': 'unit per kg body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Number of Patients With at Least One Episode of Symptomatic Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Insulin Glargine and Sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\<FPG ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food."}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the treatment period (12 weeks) plus 7 days after last dose', 'description': 'Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement \\<= 70mg/dL \\[3.9 mmol/L\\]', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure was the safety population'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight From Baseline to Study Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Insulin Glargine and Sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\<FPG ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food."}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '2.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value', 'description': 'Change = study endpoint - baseline', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was the safety population with both baseline and endpoint values available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combination Insulin Glargine and Sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\< Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'Safety Population', 'achievements': [{'comment': 'patients treated with at least one dose of insulin glargine OR one dose of sitagliptin', 'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'Treated by Combination', 'achievements': [{'comment': 'patients treated with at least one dose of insulin glargine AND one dose of sitagliptin', 'groupId': 'FG000', 'numSubjects': '111'}]}, {'type': 'Modified Intent-To-Treat Population', 'achievements': [{'comment': 'mITT population: patients treated by combination with at least 1 on-treatment efficacy measure', 'groupId': 'FG000', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Among the 445 patients who completed the EASIE study, 194 had an endpoint Glycosylated Hemoglobin A1c (HbA1c) ≥ 7%. A total of 112 patients were included in the extension study: 37 uncontrolled on previous treatment with metformin and insulin glargine and 75 uncontrolled on previous treatment with metformin and sitagliptin in the EASIE study.', 'preAssignmentDetails': 'Among the 112 included patients, two patients prematurely discontinued from the study. One of them had continued his sitagliptin treatment but never started the insulin glargine treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Combination Insulin Glargine and Sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\<FPG ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food."}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '9.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mITT population\n\nAge collected at EASIE study entry (24 weeks before baseline)', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'mITT population', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '84.6', 'spread': '21.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mITT population', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'spread': '5.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mITT population', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '129.9', 'spread': '15.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mITT population', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '80.1', 'spread': '7.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mITT population', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart Rate', 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mITT population', 'unitOfMeasure': 'beats/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '5.1', 'groupId': 'BG000', 'lowerLimit': '2.0', 'upperLimit': '8.3'}]}]}], 'paramType': 'MEDIAN', 'description': 'mITT population\n\nDuration of diabetes collected at EASIE study entry (24 weeks before baseline)', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'At least one diabetic late complication', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'mITT population\n\nDiabetic late complications: myocardial infarction, angina pectoris, coronary artery disease, heart failure, stroke, transient ischemic attack, peripheral vascular disease, diabetic neuropathy, diabetic nephropathy, diabetic retinopathy\n\nInformation collected at EASIE study entry (24 weeks before baseline)', 'unitOfMeasure': 'participants'}, {'title': 'Glycosylated Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '1.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mITT population', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose', 'classes': [{'categories': [{'measurements': [{'value': '151.5', 'spread': '46.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mITT population but due to missing values N=110', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Self-Monitored Fasting Plasma Glucose', 'classes': [{'categories': [{'measurements': [{'value': '144.4', 'spread': '38.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mITT population but due to missing values N=104', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-03', 'studyFirstSubmitDate': '2009-02-25', 'resultsFirstSubmitDate': '2012-09-03', 'studyFirstSubmitQcDate': '2009-02-25', 'lastUpdatePostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-03', 'studyFirstPostDateStruct': {'date': '2009-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)', 'timeFrame': 'study endpoint: week 12 or earlier in case of premature discontinuation'}], 'secondaryOutcomes': [{'measure': 'HbA1c: Change From Baseline to Study Endpoint', 'timeFrame': 'baseline, study endpoint: week 12 or earlier in case of premature discontinuation', 'description': 'Change = study endpoint - baseline'}, {'measure': 'Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint', 'timeFrame': 'baseline, study endpoint: week 12 or week 8 if value not available at week 12', 'description': 'SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).\n\nChange = study endpoint - baseline.'}, {'measure': '7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint', 'timeFrame': 'baseline, study endpoint: week 12 or week 8 if value not available at week 12', 'description': '7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.\n\nChange = study endpoint - baseline.'}, {'measure': 'Insulin Dose', 'timeFrame': 'baseline, week 4, week 8, week 12', 'description': 'Daily dose at the face-to-face visits'}, {'measure': 'Number of Patients With at Least One Episode of Symptomatic Hypoglycemia', 'timeFrame': 'During the treatment period (12 weeks) plus 7 days after last dose', 'description': 'Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement \\<= 70mg/dL \\[3.9 mmol/L\\]'}, {'measure': 'Change in Body Weight From Baseline to Study Endpoint', 'timeFrame': 'baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value', 'description': 'Change = study endpoint - baseline'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This study was the extension of the LANTU\\_C\\_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled).\n\nAll patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria.\n\nThe visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period.\n\nThe objectives of this extension study were:\n\n* To assess the glycemic control (HbA1c \\<7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus either insulin glargine or sitagliptin.\n* To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight and overall safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients who completed the core study LANTU\\_C\\_02761 (NCT00751114) i.e. went through the visit 14 investigation,\n* HbA1c \\>= 7 %,\n* Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1 g/day), and maintained stable for the duration of the core study\n* Ability and willingness to perform plasma blood glucose monitoring using the sponsor-provided plasma glucose meter and to complete the patient dairy,\n* Signed informed consent obtained prior any study procedure,\n* Willingness and ability to comply with the study protocol.\n\nExclusion Criteria:\n\n* Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study,\n* Treatment with insulin other than Insulin Glargine in the core study (except in case of an emergency, for a period of time less than 7 days),\n* Treatment with a non-permitted drug during the core study,\n* Pregnant or lactating women,\n* In-patient care,\n* Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry in the core study),\n* Impaired renal function: serum creatinine \\>= 1.5 mg/dL (\\>= 133µmol/L) or \\>= 1.4 mg/dL (\\>=124 µmol/L) in men and women, respectively,\n* History of sensitivity to the study drugs or to drugs with a similar chemical structure,\n* Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) \\> 3 x upper limit of normal range,\n* Alcohol or drug abuse within the last year,\n* Night shift worker,\n* Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,\n* Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant),\n* History of pancreatitis."}, 'identificationModule': {'nctId': 'NCT00851903', 'briefTitle': 'Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Combination Therapy of Insulin Glargine and Sitagliptin in Patients With Type 2 Diabetes Not Adequately Controlled by a Previous Treatment With Metformin and Either Insulin Glargine or Sitagliptin', 'orgStudyIdInfo': {'id': 'EXT_LANTU_C_02761'}, 'secondaryIdInfos': [{'id': '2008-000521-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination insulin glargine and sitagliptin', 'description': "Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \\< Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 \\<FPG ≤ 5.5 mmol/L).\n\nSitagliptin: stable dose of 100 mg once a day administered with or without food.", 'interventionNames': ['Drug: Insulin Glargine', 'Drug: Sitagliptin', 'Drug: Metformin']}], 'interventions': [{'name': 'Insulin Glargine', 'type': 'DRUG', 'otherNames': ['Lantus®'], 'description': 'Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).', 'armGroupLabels': ['Combination insulin glargine and sitagliptin']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia®'], 'description': 'Oral administration. 100mg film-coated tablets.', 'armGroupLabels': ['Combination insulin glargine and sitagliptin']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Patients continued with metformin as usual oral anti-diabetic treatment.', 'armGroupLabels': ['Combination insulin glargine and sitagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Kallithea', 'country': 'Greece', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 37.95, 'lon': 23.7}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Netanya', 'country': 'Israel', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Col. Coyoacan', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office'}, {'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'city': 'Porto Salvo', 'country': 'Portugal', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 38.72293, 'lon': -9.30473}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Guildford Surrey', 'country': 'United Kingdom', 'facility': 'Sanofi-Aventis Administrative Office'}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}