Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Glimepiride: Glimepiride (2 mg /day or 1 mg/day)tablets, orally, 24 week
Intervention2: Metformin: Metformin (500 mg bid)orally, 24 week
Control Intervention1: Glimepiride + Metformin:
Sponsors
Sanofi Synthelabo I Ltd
Eligibility
Inclusion criteria
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
Exclusion criteria: E 01. Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake�). E 02. HbA1c 9%. E 03. Age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline (week 0) to V11 (week 24).Timepoint: Change in HbA1c from baseline (week 0) to V11 (week 24). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy : Percentage of patients with HbA1c 7% and 6.5% at week 24. Change in FPG from baseline (week 0) to V11 (week 24). Safety : 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 | — |
Countries
Algeria, Colombia, Egypt, Guatemala, India, Iran (Islamic Republic of), Kuwait, Lebanon, Mexico, Morocco, Russian Federation, Saudi Arabia, South Africa, Tunisia, Turkey, Ukraine, United Arab Emirates
Contacts
Public ContactSalini JAMES
Sanofi Synthelabo (I) Ltd
Outcome results
None listed