drugset / Trial / NCT00118950

Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet

NCT00118950

Phase 4 Completed 100 enrolled Steno Diabetes Center Copenhagen
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2001-03
Primary completion
Completion
2003-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1000 mg
Comparator Repaglinide Small molecule 2 mg