Primary Objective: \- To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM. Secondary Objective: \- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM
The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. In case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows: * Screening: 3 to 27 days; * Treatment Periods each 1 day with institutionalisation from Day -1 to Day 3; * Wash-out between doses: 7 to 10 days; * End of Study visit: 7 to 10 days after last dose. * Post-study visit 84 to 112 days after last dosing. If necessary, additional post-study visit 6 to 7 months after last dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Sanofi-Aventis Administrative Office
Berlin, Germany
- Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort
Time frame: up to 7 days after dose
- Pharmacodynamics (Glucose infusion rate) time-action profile
Time frame: up to 30 hours after dose
- Pharmacokinetic parameters
Time frame: up to 168 hours after dose
- anti-insulin antibody production
Time frame: pre-dose and after 4th dose
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