Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00118950
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
- Pregnancy
- History of drug-abuse or HbA1c>10.5% at two separate visits with at least one month interval during treatment-periods.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 3 Diet-only. Wash-out period: Treatment: Diet-only: Duration: One month. 2 Placebo-Metformin. Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months. 1 Diet-only. Run-in period: Treatment: Diet-only. Duration: One month. 4 Metformin Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months. 2 Repaglinide Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months. 4 Placebo-Repaglinide. Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months.
- Primary Outcome Measures
Name Time Method HaemoglobinA1c
- Secondary Outcome Measures
Name Time Method Waist- and hip-circumference Home-monitored 7-point plasma-glucose profiles 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.). Platelet aggregation, markers of platelet activity and fibrinolytic markers fasting as well as before and after physical activity. Body-weight 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. DNA for genotyping. Adverse events and safety variables (e.g. hypoglycaemia, haemoglobin, white blood cell count, cobalamine and folate).
Trial Locations
- Locations (1)
Steno Diabetes Center
🇩🇰Gentofte, Denmark