20 Week Bridging Study in Type II DM
Phase 3
Completed
- Conditions
- Diabetes Mellitus Type II
- Registration Number
- NCT00563225
- Lead Sponsor
- Sanofi
- Brief Summary
A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and safety of insulin glargine on subjects with Type 2 Diabetes Mellitus
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Type 2 Diabetes Mellitus diagnosed at least 3 years ago
- Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry
- Treated with OHA monotherapy over at least 1 year
- HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit)
- BMI < 40 kg/m2
- No history of ketonemia
- Women of childbearing potential using the medically approved contraceptive method
- Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG.