Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes
Summary
It has been shown in previous study that progressive glycemic deterioration was associated with progressive loss of b-cell function, measured by the decrease in plasma insulin levels, irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence that thiazolidinediones could have a positive action on the b-cell function. But it has not yet been demonstrated that they could protect from a deterioration in insulin secretion in the long term. So, it appears interesting to study the long term evolution of the b-cell function and the possible protection with rosiglitazone in patients with type 2 diabetes showing evidence of loss of b-cell function with metformin alone.
Timeline
- Start
- 2004-10
- Primary completion
- 2008-10
- Completion
- 2008-10
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Rosiglitazone + Metformin 4 mg/2 g/Day vs Gliclazide + Metformin 80 mg/2 g/Day; p = 0.376; Van Elteren; note: p value is for Total AUC(0-10 min) NCT00367055 ↗
registry analysis (superiority or other test); Rosiglitazone + Metformin 4 mg/2 g/Day vs Gliclazide + Metformin 80 mg/2 g/Day; p = 0.990; Van Elteren; note: p value is for Incremental AUC(0-10 min) NCT00367055 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gliclazide | Small molecule | — | — |
| Subject | Rosiglitazone | Small molecule | — | — |
| Background | Metformin | Small molecule | — | — |