6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs With a 6-month Safety Extension Period
Overview
- Phase
- Phase 3
- Intervention
- HOE901-U300 (new formulation of insulin glargine)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 878
- Locations
- 217
- Primary Endpoint
- Change in HbA1c From Baseline to Month 6 Endpoint
- Status
- Completed
- Last Updated
- 10 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 participants with type 2 diabetes mellitus
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of:
- occurrence of nocturnal hypoglycemia
Detailed Description
The maximum study duration was up to approximately 54 weeks per participant, consisting of: * Up to 2 week screening period; it can be exceptionally extended of up to one additional week * 6-month comparative efficacy and safety treatment period * 6-month comparative safety extension period * 2-day post-treatment safety follow-up period
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
HOE901-U300
Intervention: HOE901-U300 (new formulation of insulin glargine)
Lantus
Intervention: Lantus (insulin glargine)
Outcomes
Primary Outcomes
Change in HbA1c From Baseline to Month 6 Endpoint
Time Frame: Baseline, Month 6
Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Secondary Outcomes
- Percentage of Participants With HbA1c <7% at Month 6(Month 6)
- Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Variability of Preinjection SMPG at Month 6 Endpoint(Month 6)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6(Month 6)
- Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12(Up to 12 months)
- Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6(Week 9 Up to Month 6)
- Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6(Baseline, Month 6)
- Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Change in Daily Basal Insulin Dose From Baseline to Month 6(Baseline, Month 6)
- Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint(Baseline, Month 6)