Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR439065 · 1 trial · 1 indication
| 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 ...
SAR439065 is an investigational small molecule being developed for Type 1 Diabetes Mellitus. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its metabolic activity in patients with this condition.
SAR439065 is being developed by MannKind Corporation, a biopharmaceutical company traded on NASDAQ under the ticker MNKD. The company is conducting clinical research on this investigational drug for Type 1 Diabetes Mellitus.
SAR439065 is in Phase 1 clinical development. It is an investigational drug and has not been approved for commercial use. The Phase 1 trial has been completed, and the drug remains under clinical investigation for Type 1 Diabetes Mellitus.
SAR439065 has one completed Phase 1 clinical trial, identified as NCT02470637. This study evaluated the concentration-time profile and metabolic activity of three dose levels of the drug compared with insulin lispro in 30 patients with Type 1 Diabetes Mellitus in Germany.
SAR439065 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 1 Diabetes Mellitus. The drug has completed a Phase 1 trial but has not received regulatory approval for any use.