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Label indication AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. FDA label
Also known as Afrezza®
Technosphere Insulin SAR439065 Afrezza · 1 trial · 1 indication
| 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...
Technosphere Insulin SAR439065 Afrezza is an inhaled insulin product developed by MannKind Corporation for the treatment of Type 1 Diabetes Mellitus. It is also known as Afrezza. The drug is given as a single inhaled dose and has been studied in a Phase 1 clinical trial in patients with Type 1 diabetes.
Technosphere Insulin SAR439065 Afrezza is being studied for use in Type 1 Diabetes Mellitus. The one completed clinical trial enrolled 22 adult patients with Type 1 diabetes in Germany to evaluate the pharmacokinetic and pharmacodynamic variability of a single dose of the inhaled insulin.
Technosphere Insulin SAR439065 Afrezza is developed by MannKind Corporation, which trades under the ticker MNKD. MannKind is the company behind the Technosphere inhalation technology used to deliver this insulin product.
Technosphere Insulin SAR439065 Afrezza is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was an uncontrolled, non-randomized, open-label trial, so it did not include a placebo or comparator arm.
Technosphere Insulin SAR439065 Afrezza has been studied in one completed Phase 1 trial, NCT02485327, titled PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1. The trial enrolled 22 adults with Type 1 diabetes in Germany and has completed.
Yes. Technosphere Insulin SAR439065 Afrezza is also known as Afrezza, so searches for either name refer to the same inhaled insulin product developed by MannKind Corporation. The full name reflects both the Technosphere delivery technology and the Afrezza brand name.