Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
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|ClinicalTrials.gov Identifier: NCT00118950|
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : December 8, 2008
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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 or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Metformin Drug: Repaglinide Drug: Placebo-Metformin. Drug: Placebo-Repaglinide. Other: Diet-only.||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2001|
|Study Completion Date :||March 2003|
Active Comparator: 4
Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months.
Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.
Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.
Active Comparator: 2
Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months.
Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.
Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.
Run-in period: Treatment: Diet-only. Duration: One month.
Diet-only treatment. Duration: One month.
Wash-out period: Treatment: Diet-only: Duration: One month.
Diet-only treatment. Duration: One month.
- Home-monitored 7-point plasma-glucose profiles
- Waist- and hip-circumference
- 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.).
- 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).
- Albuminuria and 24-hour blood-pressure measurements.
- Platelet aggregation, markers of platelet activity and fibrinolytic markers fasting as well as before and after physical activity.
- DNA for genotyping.
- Adverse events and safety variables (e.g. hypoglycaemia, haemoglobin, white blood cell count, cobalamine and folate).
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|Ages Eligible for Study:||40 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Type-2 diabetes, defined as:
- Age at onset of diabetes ≥ 40 years
- Fasting serum C-peptide ≥ 300 pmol/l or a non-fasting or glucagon-stimulated serum C-peptide ≥ 600 pmol/l
- No history of ketonuria or ketoacidosis.
- BMI ≤ 27 kg/m2.
- Fasting plasma-glucose ≥ 6.5 mmol/l after at least one month of diet-only treatment.
- HbA1c ≤ 9.5% at ongoing oral anti-hyperglycaemic agents. HbA1c ≥ 6.5% after minimum one month of diet-only treatment.
- Weight-loss of no more than 5.0 kg during the last 6 months prior to enrolment.
- Type-1 diabetes
- Insulin-treated type-2 diabetes
- Secondary diabetes, heart-failure
- Serum-creatinine above the upper limit
- Serum-ASAT elevated more than 3 fold above the upper limit
- Factor II-VII-X decreased below 0.7
- Ongoing coexisting illnesses with a life-shortening prognosis
- Mental retardation or reduced intellectual behaviour
- History of drug-abuse or HbA1c>10.5% at two separate visits with at least one month interval during treatment-periods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118950
|Steno Diabetes Center|
|Gentofte, Denmark, 2820|
|Study Chair:||Allan A Vaag, M. D., Chief Physician||Steno Diabetes Center Copenhagen|
|Principal Investigator:||Soeren S Lund, M. D.||Steno Diabetes Center Copenhagen|
|Other Study ID Numbers:||
|First Posted:||July 12, 2005 Key Record Dates|
|Last Update Posted:||December 8, 2008|
|Last Verified:||December 2008|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs