drugset / Trial / NCT01459809
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: \- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. Secondary Objectives: \- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone on: * Percentage of patients reaching HbA1c \< 7% * Percentage of patients reaching HbA1c \< 6.5% * Fasting Plasma Glucose (FPG) * Safety and tolerability
Timeline
- Start
- 2012-02
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glimepiride | Small molecule | 4 mg | Oral |
| Subject | Metformin | Small molecule | 2000 mg | Oral |