Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Hypoglycemic Agents

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.