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Afrezza Inhalant Product · 1 trial · 1 indication
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...
Afrezza Inhalant Product is an inhaled insulin used for the treatment of Type 2 Diabetes. It is designed to be taken at mealtime to help control blood sugar levels in adults with this condition. The product is delivered via inhalation, offering an alternative to injectable insulin.
Afrezza Inhalant Product is developed by MannKind Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol MNKD. MannKind focuses on developing innovative therapies for metabolic and other diseases, with Afrezza being one of its key product candidates.
Afrezza Inhalant Product is in Phase 3 clinical development. It has received Breakthrough Therapy designation from the FDA, which is granted to expedite the development and review of drugs that show significant promise in treating serious conditions. The product is investigational and not yet approved for commercial use.
Afrezza Inhalant Product has one completed Phase 3 clinical trial, identified by the NCT number NCT03324776. The trial, titled "Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients," enrolled 20 participants in the United States. It was an uncontrolled, non-randomized study that has been completed.
Afrezza Inhalant Product is not FDA approved. It is currently in Phase 3 clinical development and has received Breakthrough Therapy designation from the FDA, which is a status that facilitates the development and review process. The product remains investigational and is not yet available for commercial use.
Afrezza Inhalant Product is the same as Afrezza, which is the brand name for this inhaled insulin. The product is developed by MannKind Corporation and is being studied for the treatment of Type 2 Diabetes. It is delivered via inhalation and is intended for use at mealtime to manage blood sugar levels.