Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: GLIMEPIRIDE (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Mei Mao, Study Director, Affiliation: Sanofi-Aventis
Overall contact:
Public Registry GMA, Email: PublicRegistryGMA@sanofi-aventis.com
Summary
To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD
initiation mono-therapy in type 2 diabetic patients in China.
Clinical Details
Official title: Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono- Therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change in glycosylated hemoglobin (HbA1c) rate
Secondary outcome: Fasting Plasma Glucose (FPG) ratePost Prandial Glucose (PPG) rate Percentage of patients achieving HbA1c <7.0
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Public Registry GMA, Email: PublicRegistryGMA@sanofi-aventis.com
Sanofi-aventis Administrative Office, Beijing, China; Recruiting
Additional Information
Starting date: May 2009
Ending date: April 2010
Last updated: September 14, 2009
|
