Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR341402 · 2 trials · 1 indication
Maximum plasma concentration (Cmax) of SAR341402 Mix 70/30, NovoLog Mix 70/30, NovoMix 30 and SAR341402 within 24 hours
INS-AUC of SAR341402 Mix 70/30, NovoLog Mix 70/30, and NovoMix 30 from 0 to 24 hours
INS-AUC0-4H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 0 to 4 hours
INS-AUC4-12H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 4 to 12 hours
(Cohort 2) Maximum plasma concentration (Cmax) of SAR341402 Mix 70/30 and SAR341402 rapid acting solution within 24 hours
Maximum plasma concentration (Cmax) of SAR341402, NovoRapid and NovoLog within 12 hours
INS-AUC of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours
INS-AUClast is AUC from the time of dosing to the last measurable concentration of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours
Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)
| Arm | Type | Description |
|---|---|---|
| Test (T) | EXPERIMENTAL | SAR341402 Mix 70/30: single dose injection |
| Reference 1 (R1) | ACTIVE_COMPARATOR | NovoLog Mix 70/30: single dose injection |
| Reference 2 (R2) | ACTIVE_COMPARATOR | NovoMix30: single dose injection |
| Reference 3 (R3) | EXPERIMENTAL | SAR341402 rapid-acting solution: single dose injection |
| Name | Type | Description |
|---|---|---|
| SAR341402 | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| Insulin Aspart | DRUG | Pharmaceutical form: suspension for injection Route of administration: subcutaneous |
Inclusion criteria : * Total insulin dose of \< 1.0 U/kg/day. * Total basal insulin dose ≤0.4 U/kg/day. * Fasting serum C-peptide \< 0.3 nmol/L. * Anti-insulin antibody titer ≤30.0 kU/L. * Glycohemoglobin (HbA1c) ≤ 9%. * Stable insulin regimen for at least 2 months prior to study. * Normal findings...
SAR341402 is an investigational small molecule being developed by Sanofi for the treatment of Type 1 Diabetes. It is a rapid-acting insulin aspart formulation studied for its pharmacokinetics and pharmacodynamics compared to other insulin products. SAR341402 is in Phase 1 clinical development and is not yet approved.
SAR341402 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and activity in patients with Type 1 Diabetes.
SAR341402 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 82 participants enrolled. The drug is investigational and has not received regulatory approval for any use.
SAR341402 has been studied in two completed Phase 1 trials. NCT03202875 compared its pharmacokinetics and pharmacodynamics to insulin aspart in 30 adults with Type 1 Diabetes. NCT03916601 compared SAR341402 Mix 70/30 to NovoLog Mix 70/30, NovoMix 30, and SAR341402 rapid-acting solution in 52 patients.
SAR341402 is a rapid-acting insulin aspart formulation, but it is not the same as the reference product. In clinical trials, SAR341402 was compared directly to insulin aspart (NovoLog) to evaluate differences in exposure and activity in patients with Type 1 Diabetes.