Status:
COMPLETED
Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.
Eligibility Criteria
Inclusion
- Newly diagnosed T2DM and inadequately controlled with diet and exercise or T2DM diagnosed \<6 months and who had not taken oral antidiabetic medication or insulin for \>3months.
- HbA1C more than 7.5 and less than 11.
Exclusion
- Fasting plasma glucose of \>13.5mmol/L
- Type 1 Diabetes Mellitus (T1DM)
- Patient with acute illness hospitalized in last 2 months
- Patient with active liver disease, impaired renal or hepatic functions
- Known hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any other excipients of AMARYL
- Pregnant and lactating women
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT00908921
Start Date
April 1 2009
End Date
September 1 2010
Last Update
August 8 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Shanghai, China