A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin
Overview
- Phase
- Phase 1
- Intervention
- insulin glargine (HOE901)
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in 24-hour blood glucose profile measured by continuous glucose monitoring
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
Primary Objective:
- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state
Secondary Objectives:
- To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;
- To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));
- To compare the occurrence of hypoglycemia between the 2 treatments;
- To assess the safety and tolerability of a new formulation of insulin glargine.
Detailed Description
66 days
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sequence 1
Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
Intervention: insulin glargine (HOE901)
Sequence 1
Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
Intervention: insulin glargine- new formulation (HOE901)
Sequence 2
Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
Intervention: insulin glargine (HOE901)
Sequence 2
Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
Intervention: insulin glargine- new formulation (HOE901)
Outcomes
Primary Outcomes
Change in 24-hour blood glucose profile measured by continuous glucose monitoring
Time Frame: Baseline, Day 28, Day 56
Secondary Outcomes
- Hypoglycemia categorized by the definition of American Diabetes Association(Up to Day 56)
- Change in fasting plasma glucose from baseline to each treatment end by treatment(Baseline, Day 28, Day 56)
- Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment(Baseline, Day 28, Day 56)
- Change in HbA1c from baseline to each treatment end by treatment(Baseline, Day 28, Day 56)