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NCT00908921 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00908921
Other study ID # GLIME_L_04409
Secondary ID
Status Completed
Phase Phase 4
First received May 26, 2009
Last updated August 7, 2012
Start date April 2009
Est. completion date September 2010

Study information
Verified date August 2012
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 391
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• GLIMEPIRIDE
Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)

Locations
Country Name City State
China Sanofi-Aventis Administrative Office Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in glycosylated hemoglobin (HbA1c) rate week 16 No
Secondary Fasting Plasma Glucose (FPG) rate week 16 No
Secondary Post Prandial Glucose (PPG) rate week 16 No
Secondary Percentage of patients achieving HbA1c <7.0 week 16 No
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