Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM) (GREAT)
To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono- Therapy in Chinese Type 2 Diabetes Mellitus (T2DM)|
- Change in glycosylated hemoglobin (HbA1c) rate [ Time Frame: week 16 ] [ Designated as safety issue: No ]
- Fasting Plasma Glucose (FPG) rate [ Time Frame: week 16 ] [ Designated as safety issue: No ]
- Post Prandial Glucose (PPG) rate [ Time Frame: week 16 ] [ Designated as safety issue: No ]
- Percentage of patients achieving HbA1c <7.0 [ Time Frame: week 16 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
The treatment period is 16 weeks with 5 visits: at weeks 2, 4, 8, 12, 16. At every visit if Fasting Blood Glucose (FBG) >7.0mmol/L the Glimepiride dosage is increased from 1mg to 2mg or 2mg to 4mg.
At every visit if FBG<3.9mmol/L the Glimepiride dosage is decreased from 4mg to 2mg or 2mg to 1mg.
Patients who have been on 4mg for 4 weeks and FBG>11.0mmol/L at visit, another treatment can be added at the physician's discretion.
Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908921
|Sanofi-Aventis Administrative Office|
|Study Director:||Mei Mao||Sanofi|