Health Condition 1: null- In Patients With Type 2 Diabetes insufficiently controlled with basal insulin for the assessment of the efficacy and Safety Evaluation Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
g(2ndweek) -20&
g(for remaining 22 weeks)
Control Intervention1: Volume Matched Placebo: 0.10mL - 1st week. 0.15mL - 2nd Week. 0.20mL - remaining 22 weeks.
Sponsors
Sanofi Synthelabo A Sir Mathuradas Vasanji Road AndheriE Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with basal insulin with or without metformin
Exclusion criteria
Exclusion criteria: 1. HbA1c <7% or >10% 2. Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method 3. Basal insulin < 30 U/day or not at a stable dose (± 20%) for at least 3 months prior to screening. 4. Body mass index < 20 kg/m2 5. Weight change of more than 5 kg during the 3 months preceding the study 6. Participation in any previous study with AVE0010 Use of any investigational drug within 3 months prior to study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in HbA1c Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in body weightTimepoint: 24 weeks;Change from baseline in fasting plasma glucoseTimepoint: 24 weeks;Change from baseline in insulin dosesTimepoint: 24 weeks | — |
Countries
Brazil, Canada, Chile, Egypt, France, Germany, India, Italy, Mexico, Republic of Korea, Russian Federation, Turkey, United Kingdom, United States of America
Contacts
Public ContactMs Vaishali Kanade
Sanofi-Synthelabo (India) Limited
Outcome results
None listed