Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Insulin Lispro SAR342434 · 1 trial · 1 indication
Maximum Insulin (INS) concentration
Area under INS concentration time curve from 0 to last measurable concentration -
| Arm | Type | Description |
|---|---|---|
| Test (T) | EXPERIMENTAL | Insulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period |
| Reference (R) | ACTIVE_COMPARATOR | Insulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period |
| Name | Type | Description |
|---|---|---|
| Insulin Lispro SAR342434 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
Inclusion criteria : * Male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year * Total insulin dose of \<1.0 U/kg/day * Fasting serum C-peptide \<0.30 nmol/L at screening * Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%) at screening * Sta...