Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-03-03 @ 4:33 AM
Study NCT ID:
NCT02467920
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2015-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000077270', 'term': 'Exenatide'}, {'id': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}], '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': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 349}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-12', 'studyFirstSubmitDate': '2015-06-02', 'studyFirstSubmitQcDate': '2015-06-05', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin.', 'timeFrame': 'from baseline to 24-week endpoint'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c from baseline to 12 weeks endpoint', 'timeFrame': 'from baseline to 12 weeks endpoint'}, {'measure': 'The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%', 'timeFrame': '12 weeks and 24 weeks'}, {'measure': 'Fasting blood glucose', 'timeFrame': '12 weeks and 24 weeks'}, {'measure': 'Daily insulin use', 'timeFrame': 'baseline, 12 weeks and 24 weeks'}, {'measure': 'Change in body weight', 'timeFrame': 'from baseline to 12 and 24 weeks'}, {'measure': 'The incidence and rate of hypoglycaemic events during the study', 'timeFrame': 'baseline, 12 weeks and 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['exenatide', 'glargine', 'aspart 30'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Efficacy and Safety of Basal Insulin Glargine Combination with Exenatide bid vs Switching Premix Human Insulin to Aspart30 in T2DM with Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel trial.', 'detailedDescription': 'This is a multicentre, open-label, randomized and parallel trial that will compare the efficacy and safety of basal insulin glargine combination with Exenatide bid vs. switching premix human insulin to aspart30 in type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin. Approximately 248 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms: once-daily insulin glargine + twice-daily exenatide + metformin; or twice-daily aspart 30 + metformin.\n\nStudy treatment will continue for 24 weeks. The primary efficacy measure is the change in HbA1c at 24 weeks. The study consists of 3 periods: a 1-week screening (period A), a 12-week run-in period (period B) and a 24-week treatment period (period C).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent\n* Type 2 diabetic patients receiving twice-daily premixed human insulin 30 therapy ≥ 30 U/d and metformin with maximum tolerated dosage (≤ 1500mg/d)\n* HbA1c \\> 8.0 % and \\< 11.0 % (HbA1c \\> 7.0 % and \\< 10.0% at randomization)\n* Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years\n* BMI ≥ 23 and ≤ 35 kg/m2\n\nExclusion Criteria:\n\n* Type 1 diabetes or other specific types of diabetes\n* Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods\n* Uncooperative subject because of various reasons\n* Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) \\> twice the upper limits of normal\n* Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male\n* Serious chronic gastrointestinal diseases\n* Edema\n* Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction\n* Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg\n* White blood count (WBC) \\< 4.0×109/L or platelet count (PLT) \\< 90×109/L，or definite anemia (Hb：\\< 120g/L for male, \\< 110g/L for female), or other hematological diseases\n* Endocrine system diseases, such as hyperthyroidism and hypercortisolism\n* Experimental drug allergy or frequent hypoglycemia\n* Psychiatric disorders, drug or other substance abuse\n* Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy\n* Stressful situations such as surgery, serious trauma and so on\n* Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease\n* Combined use of drugs effecting glucose metabolism such as glucocorticoid\n* Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria'}, 'identificationModule': {'nctId': 'NCT02467920', 'briefTitle': 'Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Switching Premix Human Insulin to Aspart30 in T2DM With Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel Trial', 'orgStudyIdInfo': {'id': 'ESR-14-10352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glargine + exenatide', 'description': 'Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously. After a 12-week run-in period , switching premix human insulin to glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily).', 'interventionNames': ['Drug: glargine + exenatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'aspart 30', 'description': 'Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously. After a 12-week run-in period , switching premix human insulin to aspart 30 ( subcutaneous injection, twice daily).', 'interventionNames': ['Drug: aspart 30']}], 'interventions': [{'name': 'glargine + exenatide', 'type': 'DRUG', 'description': 'glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily)', 'armGroupLabels': ['glargine + exenatide']}, {'name': 'aspart 30', 'type': 'DRUG', 'description': 'aspart 30 ( subcutaneous injection, twice daily)', 'armGroupLabels': ['aspart 30']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Endocrinology', 'investigatorFullName': 'Xuefeng Yu', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}