drugset / Trial / NCT01699932
Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Primary Objective: -To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus. Secondary Objective: To assess the effects of the fixed combination of glimepiride and metformin at week 24 on: * Percentage of patients reaching HbA1c \<7% * Percentage of patients reaching HbA1c \<6.5%. * Fasting Plasma Glucose (FPG) * Safety and tolerability
Timeline
- Start
- 2012-09
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glimepiride | Small molecule | 8 mg | Oral |
| Subject | Metformin | Small molecule | 2000 mg | Oral |