At a glance
ClinicalIndex Comparison Record- ✓Males and females aged 40-75 years at screening
- ✓Type 2 diabetes mellitus diagnosed for at least 1 year by WHO criteria
- ✓Currently receiving 1.5-3 g metformin daily at stable dose for ≥8 weeks before visit 1
- ✓HbA1c between 6.5% and 8% at both visit 1 and visit 2
- ✕Type 1 diabetes
- ✕Use of hypoglycemic agents other than metformin within 3 months prior to enrollment
- ✕Fasting plasma glucose >200 mg/dL at visit 2
- ✕Insulin use within 6 months prior to visit 1 (except during pregnancy, hospitalization, trauma, or acute infection)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of the Action of the Rosiglitazone-metformin Fixed-dose Combination and of a Metformin-sulfonylurea Free Combination on the B-cell Function in Type 2 Diabetic Patients Not Controlled With Metformin Alone.
In Brief
A Phase 4 clinical trial evaluating rosiglitazone-metformin, Metformin, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 84 participants.
Detailed 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.