Status:
COMPLETED
Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Primary Objective: * To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as r...
Detailed Description
The study consists of an up to 2-week screening period, a 20-week treatment period, and a 3-day safety follow-up period. Total study duration is up to 23 weeks.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Chinese patients with type 2 diabetes mellitus, as defined by World Health Organization, diagnosed for at least 1 year at the time of screening visit and inadequately controlled with metformin
- Signed written informed consent
- Exclusion criteria:
- Type 1 diabetes mellitus
- HbA1c \< 7% or \> 10%
- Fasting plasma glucose \> 250 mg/dL (\> 13.9 mmol/L)
- Age \<18 years or Age ≥ 80 years
- Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening
- Patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT01457911
Start Date
October 1 2011
End Date
February 1 2013
Last Update
May 8 2014
Active Locations (22)
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1
Investigational Site Number 156001
Beijing, China, 100044
2
Investigational Site Number 156016
Beijing, China, 100088
3
Investigational Site Number 156003
Beijing, China, 100730
4
Investigational Site Number 156018
Beijing, China, 100730