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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02470637 | Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus | PHASE1 | COMPLETED | 30 | — | — | Jun 1, 2015 | Sep 1, 2015 | Apr 13, 2017 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| SAR439065 + insulin lispro | EXPERIMENTAL | 1 of 6 sequences with single administration of 3 dose levels of SAR439065 (Afrezza Technosphere insulin) and 3 dose levels of insulin lispro with a washout duration between dosing days (7 to 28 days) |
| Name | Type | Description |
|---|---|---|
| SAR439065 | DRUG | Pharmaceutical form:dry powder insulin Route of administration: inhalation |
| Insulin lispro | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
Inclusion criteria : * Male or female patients, between 18 and 65 years of age, inclusive, with diabetes mellitus type 1 for more than one year, as defined by the American Diabetes Association. * Total insulin dose of \<1.0 U/kg/day. * Body weight between 50.0 and 95 kg, inclusive, body mass index ...