NCT00118963

Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes

Effect of Repaglinide Versus Metformin Treatment in Combination With Insulin Biasp30 (Novologmix 70/30) Predinner on Glycemic and Non-Glycemic Cardiovascular Risk-Factors in Non-Obese Patients With Type-2-Diabetes With Unsatisfactory Glycaemic Control With Oral Hypoglycaemic Agents

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After four months run-in with repaglinide plus metformin combination-therapy, patients with HemoglobinA1c ≥6.5% will be randomized (baseline=0 month) to repaglinide 2 mg thrice-daily or metformin 1g twice-daily, both in combination with BIAsp30 (30% insulin-aspart; 70% protaminated insulin-aspart) (6U once-daily, pre-dinner) for 12 months.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Metformin	Tablets of 500 mg; 1000 mg two times daily.
DRUG	Insulin BIAsp30 (Novolog 70/30)	Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.
DRUG	Repaglinide	Tablets of 1 mg; Dosage: 2 mg three times daily.
DRUG	Placebo-Metformin	Tablets corresponding to 500 mg; two tablets two times daily.
DRUG	Placebo-Repaglinide	Tablet corresponding to 1 mg; two tablets three times daily.

Timeline

• Start date: 2003-01-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2005-07-12
• Last updated: 2008-12-08

Locations

1 site across 1 country: Denmark