A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
Overview
- Phase
- Phase 3
- Intervention
- Insulin glargine new formulation (HOE901)
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 243
- Locations
- 22
- Primary Endpoint
- Change from baseline in HbA1c
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese patients with type 1 diabetes mellitus
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.
To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia
Detailed Description
The duration of study will consist of: * Up to 2-week screening period; * 6-month open-label comparative efficacy and safety treatment period; * 6-month open-label comparative safety extension period; * 4-week post-treatment safety follow-up period
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
New formulation of insulin glargine
once daily in the evening on-top of mealtime insulin
Intervention: Insulin glargine new formulation (HOE901)
Lantus (insulin glargine)
once daily in the evening on-top of mealtime insulin
Intervention: Insulin glargine (HOE901) (Lantus)
Outcomes
Primary Outcomes
Change from baseline in HbA1c
Time Frame: baseline, 6 months
Secondary Outcomes
- Change from baseline in daily basal insulin dose(baseline, 6 months)
- Number of Patients with various types of Hypoglycemia Events(up to 6 months)
- Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)(up to 6 months)
- Change from baseline in FPG(baseline, 6 months)
- Change from baseline in pre-basal insulin injection SMPG(baseline, 6 months)
- Change from baseline in 8-point SMPG profiles(baseline, 6 months)
- Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)(baseline, 6 months)
- Change from baseline in variability of plasma glucose profile(baseline, 6 months)