Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03916601 | Comparison of Exposure and Activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30, NovoMix 30 and SAR341402 Rapid-acting Solution in Patients With Type 1 Diabetes Mellitus | PHASE1 | COMPLETED | 52 | — | — | Dec 13, 2017 | Mar 22, 2018 | Apr 25, 2022 | 1 | Germany |
| NCT03202875 | A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus | PHASE1 | COMPLETED | 30 | — | — | Nov 14, 2012 | Dec 28, 2012 | Apr 25, 2022 | 1 | Germany |
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...