drugset / Trial / NCT01495013
A Comparison of Atorvastatin and Glimepiride Fixed Dose Combination and Atorvastatin and Glimepiride Loose Combination in the Treatment of Patients With Type 2 Diabetes Mellitus
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this 20 week study is to show that glimepiride/atorvastatin fixed dose combination tablet is safe and as effective as atorvastatin + glimepiride combination taken as separate tablets, in improving glycaemic control (glycated haemoglobin, HbA1c) and cholesterol levels (Low-density lipoprotein, LDL) in diabetic subjects, who are inadequately controlled on a stable dose of metformin. Eight dose combinations will be included.
Timeline
- Start
- 2011-12
- Primary completion
- 2013-04
- Completion
- 2013-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atorvastatin | Small molecule | 10 mg | Oral |
| Comparator | Atorvastatin | Small molecule | 20 mg | Oral |
| Comparator | Glimepiride | Small molecule | 1 mg | Oral |
| Comparator | Glimepiride | Small molecule | 2 mg | Oral |
| Comparator | Glimepiride | Small molecule | 3 mg | Oral |
| Comparator | Glimepiride | Small molecule | 4 mg | Oral |