Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus
Phase 1
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine HOE901
- Registration Number
- NCT01349855
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen
Secondary Objective:
To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen
- Detailed Description
The study duration per patient will be 33 to 68 days including 2 treatment periods of 10 days each separated by a wash-out period of 7-21 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 Insulin glargine HOE901 Dose Level 1 Cohort 2 Insulin glargine HOE901 Dose Level 2
- Primary Outcome Measures
Name Time Method Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory up to day 10 of each period
- Secondary Outcome Measures
Name Time Method Glucose infusion rate up to day 10 of each period Pharmacokinetic parameter : Cmax up to day 10 of each period Pharmacokinetic parameter : Tmax up to day 10 of each period Pharmacokinetic parameter : AUC up to day 10 of each period
Trial Locations
- Locations (1)
Investigational site number 276001
🇩🇪Neuss, Germany