Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM) (GREAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00908921|
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : August 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: GLIMEPIRIDE||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||391 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono- Therapy in Chinese Type 2 Diabetes Mellitus (T2DM)|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
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)
- Change in glycosylated hemoglobin (HbA1c) rate [ Time Frame: week 16 ]
- Fasting Plasma Glucose (FPG) rate [ Time Frame: week 16 ]
- Post Prandial Glucose (PPG) rate [ Time Frame: week 16 ]
- Percentage of patients achieving HbA1c <7.0 [ Time Frame: week 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908921
|Sanofi-Aventis Administrative Office|
|Study Director:||Mei Mao||Sanofi|