Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus
Phase 1
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine HOE901Drug: Insulin glargine - New formulation HOE901
- Registration Number
- NCT01493115
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus®
Secondary Objective:
To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation
- Detailed Description
The study duration per patient will be 4 to 12 weeks including 3 treatment periods each separated by a wash-out period of 6-20 days
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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 dose 1) - Test2 (insulin glargine - new formulation dose 2) Sequence 1 Insulin glargine - New formulation HOE901 Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) Sequence 2 Insulin glargine HOE901 Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) Sequence 2 Insulin glargine - New formulation HOE901 Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) Sequence 3 Insulin glargine HOE901 Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) Sequence 3 Insulin glargine - New formulation HOE901 Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1)
- Primary Outcome Measures
Name Time Method Glucose infusion rate up to day 2 of each period
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameter : Cmax up to day 2 of each period Pharmacokinetic parameter : Tmax up to day 2 of each period Pharmacokinetic parameter : AUC up to day 2 of each period Number of patients with adverse events up to day 3 of each period Safety-related parameters including electrocardiogram, vital signs and laboratory tests up to day 3 of each period
Trial Locations
- Locations (1)
Investigational Site Number 392001
🇯🇵Fukuoka-Shi, Japan