Recruitment

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 participant, 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 administ...

The maximum study duration was up to approximately 58 weeks per participant, 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 #
NCT01499082
Collaborators
Not Provided
Investigators
Study Director: Clinical Sciences & Operations Sanofi