Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR161271 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 : SAR161271 0.3 U/kg | EXPERIMENTAL | Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp |
| Cohort 2 : SAR161271 0.6 U/kg | EXPERIMENTAL | Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp |
| Cohort 3 : SAR161271 1.2 U/kg | EXPERIMENTAL | Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp |
| Name | Type | Description |
|---|---|---|
| SAR161271 | DRUG | Pharmaceutical form:Solution for injection Route of administration: subcutaneous |
| Insulin glargine HOE901 | DRUG | Pharmaceutical form:Solution for injection Route of administration: subcutaneous |
Inclusion criteria: * Patients who have type 1 diabetes mellitus (T1DM) as defined by American Diabetes Association average total insulin dose of \<1.2 U/kg/day * Fasting negative serum C-peptide (\<0.3 nmol/L) * Glycated hemoglobin (HbA1c) \< or = 9% * Stable insulin regimen for at least 2 months ...
SAR161271 is an investigational small molecule being studied for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
SAR161271 is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 1 clinical development.
SAR161271 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use. One Phase 1 study has been completed.
SAR161271 has one completed Phase 1 clinical trial, identified as NCT01053728. This study examined how single rising doses of the drug are absorbed and act in patients with Type 1 Diabetes Mellitus.
SAR161271 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 1 Diabetes Mellitus. Its safety and efficacy have not been established.