Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus
Phase 1
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: insulin glargine (HOE901)Drug: insulin glargine- new formulation (HOE901)
- Registration Number
- NCT01676233
- Lead Sponsor
- Sanofi
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 insulin glargine (HOE901) Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal Sequence 1 insulin glargine- new formulation (HOE901) Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal Sequence 2 insulin glargine (HOE901) Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal Sequence 2 insulin glargine- new formulation (HOE901) Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
- Primary Outcome Measures
Name Time Method Change in 24-hour blood glucose profile measured by continuous glucose monitoring Baseline, Day 28, Day 56
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Investigational Site Number 392001
🇯🇵Kumamoto-Shi, Japan