Adults with type 2 diabetes that is not well controlled on oral antidiabetes medications experienced a significant drop in HbA1c after adding Afrezza inhaled insulin to their regimen, according to research in Diabetes Care.
In a double blind, placebo-controlled, international phase 3 study conducted in Brazil, Russia, Ukraine and the United States, researchers found that participants assigned Afrezza (insulin human [rDNA origin]) inhalation powder, MannKind Corporation) saw decreases in postprandial blood glucose and minimal weight gain when compared with participants assigned an inhaled placebo.
Julio Rosenstock, MD, of the Dallas Diabetes and Endocrine Center, and colleagues analyzed data from 353 adults with type 2 diabetes for at least 12 months with an HbA1c between 7.5% and 10% prescribed metformin alone or two or more oral antidiabetes agents. Researchers randomly assigned prandial Technosphere inhaled insulin (n = 177) or prandial Technosphere inhaled placebo (n = 176) as an add-on to their oral antidiabetes regimen for 24 weeks. Researchers stratified randomization by region and antidiabetes regimen.
Researchers titrated the inhaled insulin dose weekly during the first 12 weeks of treatment based on glucose levels to target 90-minute postprandial glucose levels of 110 mg/dL to 160 mg/dL. Participants were permitted to take a supplemental dose if the 90-minute postprandial glucose level was at least 180 mg/dL. Researchers adjusted doses only for safety reasons during the remaining 12 weeks of the study.
Researchers found that Technosphere insulin reduced HbA1c in participants by 0.8% from a baseline of 8.3%; the placebo group saw a reduction of 0.4%. In addition, more inhaled insulin participants achieved an HbA1c of 7% or less when compared with the placebo group (38% vs. 19%; P = .002). Participants in the inhaled insulin group also experienced an average weight gain of 0.5 kg; the placebo group lost an average of 1.1 kg (P < .0001). Respiratory adverse events were common in both groups; the most commonly reported adverse event in both groups was a mild, dry cough (23.7% for insulin group; 19.9% for placebo group), leading 1.1% of insulin group participants and 3.4% of placebo group participants to discontinue treatment. Both groups had a decline in forced expiratory volume that resolved once treatment was discontinued.
“These results provide the basis for prandial [Technosphere insulin] as a viable option for those who require initiation of insulin but are reluctant to accept injectable therapy,” the researchers wrote. “It is conceivable that more rigorous titration regimens would have resulted in lower HbA1c reductions.”
The FDA approved inhaled Technosphere insulin in June 2014, noting that it is not a substitute for long-acting insulin. For use among adults with type 1 diabetes, inhaled insulin must be used in combination with long-acting insulin.
Technosphere insulin displays a boxed warning that acute bronchospasms have been observed in patients with asthma and chronic obstructive pulmonary disease (COPD); due to this risk, it should not be used in patients with chronic lung disease, such as asthma or COPD. – by Regina Schaffer
Disclosure: Rosenstock reports participating in advisory boards or receiving honoraria, consulting fees or research grants from Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Intarcia, Janssen, Lexicon, MannKind Corporation, Merck, Novartis, Novo Nordisk, Roche, Sanofi, Takeda. MannKind Corporation funded this study. Sanofi has a worldwide license for Technosphere insulin from MannKind Corporation.