AFREZZA® (insulin human) Inhalation Powder: A Review in Diabetes Mellitus.

Area of Science:

• Pharmacology
• Endocrinology
• Respiratory Medicine

Background:

• Afrezza (insulin human) is a rapid-acting Technosphere® insulin (TI) delivered via an oral inhaler for prandial insulin needs in diabetes.
• It utilizes a dry powder formulation for deep lung delivery and systemic absorption.
• TI aims to address barriers to insulin initiation, including injection phobia and concerns about hypoglycemia and weight gain.

Purpose of the Study:

• To evaluate the efficacy and tolerability of prandial Afrezza (insulin human) inhalation powder in patients with type 1 and type 2 diabetes.
• To compare Afrezza's glycemic control and adverse events with subcutaneous insulin aspart and placebo.

Main Methods:

• Phase III trials involving patients with type 1 diabetes (T1DM) and type 2 diabetes (T2DM).
• Randomized, open-label (Trial 171) and double-blind, placebo-controlled (Trial 175) study designs.
• Assessment of glycated haemoglobin (HbA1c), fasting plasma glucose, hypoglycemia, body weight, and adverse events.

Main Results:

• In T1DM patients, prandial TI via Gen2 inhaler showed noninferior HbA1c lowering compared to subcutaneous insulin aspart, with significantly lower fasting glucose, less hypoglycemia, and less bodyweight gain.
• In T2DM patients, prandial TI via Gen2 inhaler demonstrated superior HbA1c lowering versus inhaled placebo.
• Cough was the most frequent non-hypoglycemia adverse event, generally mild and decreasing over time.

Conclusions:

• Insulin human inhalation powder is an effective and generally well-tolerated prandial treatment for hyperglycemia in T1DM and T2DM.
• It may offer a valuable alternative for patients hesitant to start insulin therapy due to injection-related fears or concerns about side effects.