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Sponsored by: |
Steno Diabetes Center |
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Information provided by: | Steno Diabetes Center |
ClinicalTrials.gov Identifier: | NCT00118950 |
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.
Methods: 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.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: Metformin Drug: Repaglinide Drug: Placebo-Metformin. Drug: Placebo-Repaglinide. Other: Diet-only. |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 100 |
Study Start Date: | March 2001 |
Estimated Study Completion Date: | March 2003 |
Arms | Assigned Interventions |
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4: Active Comparator
Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months.
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Drug: Metformin
Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.
Drug: Placebo-Repaglinide.
Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.
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2: Active Comparator
Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months.
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Drug: Repaglinide
Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.
Drug: Placebo-Metformin.
Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.
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1
Run-in period: Treatment: Diet-only. Duration: One month.
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Other: Diet-only.
Diet-only treatment. Duration: One month.
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3
Wash-out period: Treatment: Diet-only: Duration: One month.
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Other: Diet-only.
Diet-only treatment. Duration: One month.
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Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Type-2 diabetes, defined as:
Exclusion Criteria:
Denmark | |
Steno Diabetes Center | |
Gentofte, Denmark, 2820 |
Study Chair: | Allan A Vaag, M. D., Chief Physician | Steno Diabetes Center |
Principal Investigator: | Soeren S Lund, M. D. | Steno Diabetes Center |
Study ID Numbers: | ReMet |
Study First Received: | July 1, 2005 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00118950 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency |
Hypoglycemic Agents Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Repaglinide |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Repaglinide |