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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03324776 | Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients | PHASE3 | COMPLETED | 20 | — | — | Oct 16, 2017 | Jun 10, 2020 | Jun 26, 2024 | 1 | United States |
Change in percentage of HbA1c from baseline to 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher and 11.5% or lower
| Arm | Type | Description |
|---|---|---|
| Addition of mealtime Afrezza Inhalation Powder | OTHER | Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm |
| Name | Type | Description |
|---|---|---|
| Afrezza Inhalant Product | DRUG | Mealtime Ultra-Rapid Acting Insulin |
Inclusion Criteria: * Adult type 2 diabetes patients age 18 or older * HbA1c ≥ 7.5% and ≤ 11.5% after at least 6 months treatment with diabetes medication. Treatment may include oral agents, basal insulin or Glucagon-like peptide-1 (GLP-1) in any combination. * Patient and provider agree not to add...