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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02485327 | PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM) | PHASE1 | COMPLETED | 22 | — | — | Jul 1, 2015 | Nov 1, 2015 | Mar 15, 2017 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Afrezza® | EXPERIMENTAL | Two-period, replicate single dose, euglycemic clamp study. There will be 2 treatment periods with a replicate administration of 1 dose of Afrezza TI (40U) in both periods. Each patient will be given a replicate administration of 1 dose level of Afrezza TI with washout duration between treatment periods (5-19 days between periods, ie, 7 to 21 days between dosing occasions). |
| Name | Type | Description |
|---|---|---|
| Technosphere Insulin SAR439065 Afrezza® | DRUG | Pharmaceutical form: dry powder Route of administration: oral inhalation |
Inclusion criteria : * Body weight between 50 and 95 kg, inclusive, body mass index between 18.5 and 29 kg/m², inclusive. * Fasting serum C-peptide \<0.3 nmol/L. * Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%). * Stable insulin regimen for at least 2 months prior to study (with respect to safety of th...