Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 800
Summary
- Conditions
- Type 2 Diabetes Mellitus
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The maximum study duration was up to approximately 58 weeks per participants, consisting of: up to 2 week screening period 6-month comparative efficacy and safety treatment period 6-month comparative safety extension period 4-week safety follow-up period in a subset of participants a 3-month adminis...
The maximum study duration was up to approximately 58 weeks per participants, consisting of: up to 2 week screening period 6-month comparative efficacy and safety treatment period 6-month comparative safety extension period 4-week safety follow-up period in a subset of participants a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300
Tracking Information
- NCT #
- NCT01499095
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Sciences & Operations Sanofi
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