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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01445951 | Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period | PHASE3 | COMPLETED | 518 | — | — | Sep 1, 2011 | Jun 1, 2013 | Oct 22, 2014 | 90 | United States, Brazil +2 |
| NCT07224321 | INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes | PHASE2 | RECRUITING | 100 | — | — | Feb 4, 2026 | Sep 1, 2027 | May 22, 2026 | 10 | United States |
| NCT01544881 | Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 17 | — | — | Mar 1, 2012 | Jan 1, 2013 | Jan 25, 2013 | 1 | United States |
Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24
Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit
| Arm | Type | Description |
|---|---|---|
| Technosphere® Insulin with MedTone C Inhaler | EXPERIMENTAL | Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry |
| Aspart Group | ACTIVE_COMPARATOR | Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry |
| Technosphere ® Insulin-Gen2 Group | EXPERIMENTAL | Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry |
| Afrezza (Technosphere Insulin) + Basal Insulin | EXPERIMENTAL | Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks. |
| TI Inhalation Powder | EXPERIMENTAL | Technosphere Insulin Inhalation Powder using the Gen2C inhaler |
| RAA | ACTIVE_COMPARATOR | Rapid Acting Analog |
| Name | Type | Description |
|---|---|---|
| Technosphere® Insulin with MedTone C Inhaler | DRUG | Inhalation Powder and injectable insulin |
| Technosphere ®Insulin with Gen2 Inhaler | DRUG | Inhalation Powder and injectable insulin |
| Insulin Aspart in combination with a basal insulin | DRUG | Injectable insulin |
| Technosphere Insulin | DRUG | 2 unit |
| Basal insulin | DRUG | subcutaneously-injected basal insulin |
| Technosphere Insulin Inhalation Powder | DRUG | Inhalation Powder using the Gen2C inhaler |
| Rapid Acting Analog | DRUG | Subcutaneous Injection |
Inclusion Criteria: * Men and women = 18 years of age * Clinical diagnosis of type 1 diabetes mellitus for at least 12 months * Body mass index (BMI) = 38 kg/m2 * Stable dose of basal/bolus insulin therapy for at least 3 months with an FPG consistently \< 220 mg/dL: * HbA1c = 7.5% and = 10.0% * Fas...