Technosphere insulin (Afrezza); a new form of inhaled insulin

This study evaluated the safety and efficacy of Technosphere insulin in type 2 diabetic patients.

Current standards of care with type 2 diabetes focus on achieving and maintaining stringent glycemic (glucose) control. The use of prandial insulin (Humalog; taken at mealtimes) added to oral antidiabetic agents has recently been shown to reduce HbA1C levels more than basal insulin (Levemir; small, steady background amounts of insulin) combined with oral agents. HbA1c is a measurement of average blood glucose levels over the past 3 months. However, many patients are reluctant to initiate insulin treatment, often due to lifestyle/convenience issues, or fear of needles and injections.

Technosphere insulin (Afrezza) has very recently been approved by the FDA for treatment of type 1 and type 2 diabetes. Technosphere insulin is a form of inhaled insulin delivered via a handheld, pocket-sized inhaler that is rapidly absorbed (15 min) with a fast onset of action (25 – 30 minutes) and a short duration of action (2 – 3 hours). This closely mimics the natural insulin responses that follow a meal.

The authors evaluated the safety and efficacy of Technosphere insulin in type 2 diabetic patients whose diabetes was not controlled with oral antidiabetic agents.

107 patients with type 2 diabetes completed the 12-week study. Prior to the study, patients had not taken insulin. Patients were randomized to receive either Technosphere insulin or Technosphere powder (insulin formulated as a dry powder that acted as a placebo). Subjects were instructed to use the inhaler just before the first mouthful of food at each main or substantive meal for a total of three to four doses each day.

After 2 weeks, average HbA1c levels decreased by 0.7% in the Technosphere insulin group compared to 0.3% in the Technosphere powder group. For those with HbA1c levels between 6.6 – 7.9% at the beginning of the study, the decrease was 0.5% for Technosphere insulin compared to 0.2% for Technosphere powder. For those with HbA1c levels between 8 – 10.5% at the beginning of the study, the decrease was 1.2% for Technosphere insulin compared to 0.4% for Technosphere powder.

Compared to the beginning of the study, postprandial glucose excursions (the change in glucose concentration from before to after a meal) were reduced by 56% with Technosphere insulin. Maximal glucose concentration following a meal was reduced by 43% with Technosphere insulin compared to Technosphere powder.

42.6% of patients taking Technosphere insulin had more than one hypoglycemic event (dangerously low glucose levels) compared with 35.5% in the Technosphere powder group. Coughing episodes were also similar in both groups; 29.5% of Technosphere insulin patients and 24.7% of Technosphere powder patients experienced more than one coughing episode. Most episodes of coughing were reported to occur within 10 minutes of study drug administration. Those in the Technosphere insulin group lost on average 0.1 kg compared to a loss of 0.9 kg in the Technosphere powder group, but this was not deemed to be significant.

The authors stated that Technosphere insulin was well tolerated and substantially reduced HbA1C levels and meal-related glucose excursions in type 2 diabetic patients.

The study was funded by MannKind Corporation who also developed Technosphere insulin.