drugset / Trial / NCT01453049
An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose combination tablet will safely and effectively control glycemia as first-line oral therapy in drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of treatment with rosiglitazone/glimepiride to treatment with glimepiride alone. The primary objective is to demonstrate superiority of rosiglitazone/glimepiride to glimepiride in lowering Glycosylated Hemoglobin (HbA1c).
Timeline
- Start
- 2010-04
- Primary completion
- 2010-10
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glimepiride | Small molecule | 1 mg | Oral |
| Comparator | Glimepiride | Small molecule | 2 mg | Oral |
| Comparator | Glimepiride | Small molecule | 4 mg | Oral |
| Subject | Rosiglitazone | Small molecule | 4 mg | Oral |