Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes
Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
Participant gender:
Summary
Aim:
The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular
events in obese patients with type-2-diabetes treated with metformin compared with other
hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese
patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when
diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of
cardiovascular events, the use of metformin for this sub-group of patients might be more
beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents
(OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence
exist for choosing the optimal class of OHA to be combined with insulin. The aim of the
project is therefore to investigate the effect of metformin vs. an insulin-secretagogue
(repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular
risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone.
Methodology:
Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese
(BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment
with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart
30/70, BIAsp30) for a period of 12 months.
Phase:
Phase 4
Details
Lead Sponsor:
Steno Diabetes Center Steno Diabetes Center Copenhagen