Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus
- Conditions
- Type1 Diabetes
- Interventions
- Drug: Insulin glargine new formulation HOE901
- Registration Number
- NCT01838083
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses
Secondary Objective:
* To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the insulin glargine reference formulation R in steady state conditions after 6 once-daily SC doses
* To assess the safety and tolerability of the test and reference formulations of two new insulin glargine formulations
- Detailed Description
Total study duration per subject: 29 to 64 days including screening visit
Duration of each part of the study for one subject:
* Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3)
* Treatment Period 1 and 2: 8 days (dosing on 6 days)
* Washout between last/1st dosing days of the treatment periods: 7-21 days (preferentially 7 days) End-of-Study Visit: 7-10 days after last dosing
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Insulin glargine new formulation (test T formulation) Insulin glargine new formulation HOE901 Once daily for 6 days Insulin glargine new formulation (reference R formulation) Insulin glargine new formulation HOE901 Once daily for 6 days
- Primary Outcome Measures
Name Time Method Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6 24-hours (D6 to D7)
- Secondary Outcome Measures
Name Time Method Maximum insulin concentration (INS-Cmax) 24-hours (D6 to D7) Time to INS-Cmax (INS-tmax) 24-hours (D6 to D7) Time to reach 50% of INS-AUC0-24 (T50%-INS-AUC0-24) 24-hours (D6 to D7) Area under the body-weight-standardized Glucose Infusion Rate (GIR) within 24 hours (GIR-AUC0-24h) after dosing on Day 6 during the clamp 24-hours (D6 to D7) Maximum smoothed body weight standardized glucose infusion rate (GIRmax) 24-hours (D6 to D7) Time to GIRmax (GIR-Tmax) 24-hours (D6 to D7) Time to reach at least 50% of GIR-AUC0-24 (T50%-GIR-AUC0-24) 24-hours (D6 to D7) Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different prespecified blood glucose levels) 24-hours (D6 to D7) Safety as measured by adverse events/serious adverse events, ohypoglycemia events, physical examinations, clinical laboratory, electrocardiograms, vital signs, injection site reactions and anti-insulin antibodies. up to 9 weeks
Trial Locations
- Locations (1)
Investigational Site Number 276001
🇩🇪Neuss, Germany