Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1
Phase 1
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine HOE901
- Registration Number
- NCT01146678
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug
Secondary Objectives:
* to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug
* to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix
- Detailed Description
The study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lantus(insulin glargine)/lixisenatide on-site mix Lixisenatide AVE0010 Single dose injection of an on site mix of Lantus U100 and lixisenatide (800µg/mL in Lantus U100) at one peri-umbilical site under fasting conditions Lantus(insulin glargine)/lixisenatide on-site mix Insulin glargine HOE901 Single dose injection of an on site mix of Lantus U100 and lixisenatide (800µg/mL in Lantus U100) at one peri-umbilical site under fasting conditions lixisenatide + Lantus (insulin glargine) Insulin glargine HOE901 Single dose, separate injection simultaneous injections of Lantus U100 and lixisenatide (100µg/mL) at opposite peri-umbilical sites within 1 minute under fasting conditions lixisenatide + Lantus (insulin glargine) Lixisenatide AVE0010 Single dose, separate injection simultaneous injections of Lantus U100 and lixisenatide (100µg/mL) at opposite peri-umbilical sites within 1 minute under fasting conditions
- Primary Outcome Measures
Name Time Method Area under the plasma lixisenatide concentration curve (LIX-AUClast) 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax) 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
- Secondary Outcome Measures
Name Time Method Area under the plasma lixisenatide concentration curve (AUC) 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period Time to Cmax (Tmax ) for lixisenatide 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period Area under the body weight standardized glucose infusion rate curve (GIR) within 24 h (GIR-AUC0-24) 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period Time to 50% of the GIR-AUC within 24 h (T50%-GIR AUC0-24) 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period Maximum smoothed body weight standardized glucose infusion rate GIRmax 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period Time to GIRmax (GIR-Tmax) 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇩🇪Berlin, Germany