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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: GLIMEPIRIDE

• Registration Number: NCT00908921
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	GLIMEPIRIDE	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.

Primary Outcome Measures

Name	Time	Method
Change in glycosylated hemoglobin (HbA1c) rate	week 16

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (FPG) rate	week 16
Post Prandial Glucose (PPG) rate	week 16
Percentage of patients achieving HbA1c <7.0	week 16

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇳 Shanghai, China