drugset / Trial / NCT01420692
The Effects of Insulin Detemir and Gliclazide-MR Treatments on Endothelial Functions in Patients With Type 2 Diabetes
Completed
64 enrolled
Ankara University
Hacettepe University · collabThe Scientific and Technological Research Council of Turkey · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to analyze the effects of the addition of sulfonylurea (gliclazide MR) or ,alternatively, basal insulin (insulin detemir) to life-style modification and metformin treatment as a second step treatment in type 2 diabetes mellitus on endothelial cell functions. The second goal is to identify the effects of these treatment alternatives on body-mass index, the changes in body fat mass, insulin resistance and on the insulin secretion capacity of beta cells. The third aim of this study is to determine the success rates of these treatment alternatives on glycemic control at 6 months follow-up.
Timeline
- Start
- 2010-06
- Primary completion
- 2012-04
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gliclazide MR | Small molecule | 30 mg | Oral |
| Comparator | Gliclazide MR | Small molecule | 120 mg | Oral |
| Comparator | insulin detemir | Protein / enzyme biologic | — | Subcutaneous |