Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-01 @ 10:31 AM
Study NCT ID:
NCT00118950
Status:
COMPLETED
Last Update Posted:
2008-12-08
First Post:
2005-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
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': 'D008687', 'term': 'Metformin'}, {'id': 'C072379', 'term': 'repaglinide'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2003-03'}, 'lastUpdateSubmitDate': '2008-12-05', 'studyFirstSubmitDate': '2005-07-01', 'studyFirstSubmitQcDate': '2005-07-01', 'lastUpdatePostDateStruct': {'date': '2008-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HaemoglobinA1c'}], 'secondaryOutcomes': [{'measure': 'Home-monitored 7-point plasma-glucose profiles'}, {'measure': 'Body-weight'}, {'measure': 'Waist- and hip-circumference'}, {'measure': 'Fasting and postprandial (after a standard test-meal) measures of plasma-glucose, insulin, c-peptide, free fatty acids, lipoproteins, triglycerides and other markers related to lipid-metabolism (e.g. apo-lipoproteins, lipoprotein particle size etc.).'}, {'measure': 'Biomarkers related to inflammation, endothelial dysfunction and fibrinolysis (e.g. hs-CRP, TNF-alpha, IL-6, ICAM, VCAM, E-selectin, vWF, PAI-1 and t-PA, adiponectin, ADMA, AGE-peptides).'}, {'measure': 'Albuminuria and 24-hour blood-pressure measurements.'}, {'measure': 'Platelet aggregation, markers of platelet activity and fibrinolytic markers fasting as well as before and after physical activity.'}, {'measure': 'DNA for genotyping.'}, {'measure': 'Adverse events and safety variables (e.g. hypoglycaemia, haemoglobin, white blood cell count, cobalamine and folate).'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Background: Metformin is the first drug of choice in obese patients with type-2 diabetes (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In non-obese T2DM patients insulin-secretagogues are empirically used as first choice. The aim of this study was to evaluate the effect of metformin versus an insulin-secretagogue, repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in non-obese patients with T2DM.\n\nMethods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96 non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d). followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months with a one month wash-out between interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nType-2 diabetes, defined as:\n\n* Age at onset of diabetes ≥ 40 years\n* Fasting serum C-peptide ≥ 300 pmol/l or a non-fasting or glucagon-stimulated serum C-peptide ≥ 600 pmol/l\n* No history of ketonuria or ketoacidosis.\n* BMI ≤ 27 kg/m2.\n* Fasting plasma-glucose ≥ 6.5 mmol/l after at least one month of diet-only treatment.\n* HbA1c ≤ 9.5% at ongoing oral anti-hyperglycaemic agents. HbA1c ≥ 6.5% after minimum one month of diet-only treatment.\n* Weight-loss of no more than 5.0 kg during the last 6 months prior to enrolment.\n\nExclusion Criteria:\n\n* Type-1 diabetes\n* Insulin-treated type-2 diabetes\n* Secondary diabetes, heart-failure\n* Serum-creatinine above the upper limit\n* Serum-ASAT elevated more than 3 fold above the upper limit\n* Factor II-VII-X decreased below 0.7\n* Ongoing coexisting illnesses with a life-shortening prognosis\n* Mental retardation or reduced intellectual behaviour\n* Pregnancy\n* History of drug-abuse or HbA1c\\>10.5% at two separate visits with at least one month interval during treatment-periods.'}, 'identificationModule': {'nctId': 'NCT00118950', 'briefTitle': 'Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'Effect of Metformin Versus Repaglinide Treatment on Glycemic Control and Non-Glycaemic Cardiovascular Risk Factors in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet', 'orgStudyIdInfo': {'id': 'ReMet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months.', 'interventionNames': ['Drug: Metformin', 'Drug: Placebo-Repaglinide.']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months.', 'interventionNames': ['Drug: Repaglinide', 'Drug: Placebo-Metformin.']}, {'type': 'OTHER', 'label': '1', 'description': 'Run-in period: Treatment: Diet-only. Duration: One month.', 'interventionNames': ['Other: Diet-only.']}, {'type': 'OTHER', 'label': '3', 'description': 'Wash-out period: Treatment: Diet-only: Duration: One month.', 'interventionNames': ['Other: Diet-only.']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.', 'armGroupLabels': ['4']}, {'name': 'Repaglinide', 'type': 'DRUG', 'description': 'Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.', 'armGroupLabels': ['2']}, {'name': 'Placebo-Metformin.', 'type': 'DRUG', 'description': 'Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.', 'armGroupLabels': ['2']}, {'name': 'Placebo-Repaglinide.', 'type': 'DRUG', 'description': 'Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.', 'armGroupLabels': ['4']}, {'name': 'Diet-only.', 'type': 'OTHER', 'description': 'Diet-only treatment. Duration: One month.', 'armGroupLabels': ['1', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Steno Diabetes Center', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}], 'overallOfficials': [{'name': 'Allan A Vaag, M. D., Chief Physician', 'role': 'STUDY_CHAIR', 'affiliation': 'Steno Diabetes Center Copenhagen'}, {'name': 'Soeren S Lund, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steno Diabetes Center Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}}}}