An clinical trial to compare the combination and alone of 2 drugs, glimepiride and metformin in patients with type 2 diabetes
Phase 3
Completed
- Conditions
- Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2012/08/002846
- Lead Sponsor
- Sanofi Synthelabo I Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1116
Inclusion Criteria
1. Patients with type 2 diabetes mellitus, as defined by the World Health Organization diagnosed within one year prior to the screening visit, and not on antidiabetic agents for at least 3 months.
2. Signed informed consent, obtained prior to any study procedure.
Exclusion Criteria
E 01. Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic
disorders, drug or chemical agent intakeâ?¦).
E 02. HbA1c < 7.6% or > 9%.
E 03. Age < 18 or > 78 years old years.
E 04. Body mass index (BMI) > 35 kg/m².
E 05. Patients currently receiving or who have received any hypoglycemic agent within 3
months before screening visit.
Further details of exclusion criteria can be made available on request.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline (week 0) to V11 (week 24).Timepoint: Change in HbA1c from baseline (week 0) to V11 (week 24).
- Secondary Outcome Measures
Name Time Method Efficacy : <br/ ><br>Percentage of patients with HbA1c 7% and 6.5% at week 24. Change in FPG from baseline (week 0) to V11 (week 24). <br/ ><br>Safety : <br/ ><br>Adverse events, serious adverse event, physical examination (including body weight), vital signs, hematology, serum chemistry Frequency and incidence of hypoglycemia during the study period.Timepoint: Week 24