Status:
COMPLETED
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
Primary Objective: \- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatme...
Detailed Description
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period where patient is assigned to one of the three arms according ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients with type 2 diabetes mellitus, as defined by the World Health Organization (WHO), diagnosed within one year prior to the screening visit
- Signed informed consent, obtained prior to any study procedure
- Exclusion criteria
- Age \< 18 and =\> 78 years old
- HbA1c \< 7.6% or \> 9%
- BMI \> 35 kg/m2
- Diabetes other than type 2 diabetes (e.g.: type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...)
- Subjects currently receiving or who have received any hypoglycemic agent within 3 months before screening visit
- 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 :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT01459809
Start Date
February 1 2012
End Date
January 1 2014
Last Update
January 21 2015
Active Locations (55)
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1
Investigational Site Number 01206
Algeries, Algeria
2
Investigational Site Number 01203
Oran, Algeria, 31000
3
Investigational Site Number 01205
Sétif, Algeria, 19000
4
Investigational Site Number 17003
El Espinal, Colombia