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Inhaled insulin improved glycemic control better than powder
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Patients with type 2 diabetes randomly assigned to Technosphere inhaled insulin for 12 weeks experienced greater improvements in HbA1c and postprandial glucose concentrations than with Technosphere powder.
Researchers at various U.S. institutions, including Dallas Diabetes and Endocrine Center and the University of Texas Health Science Center, studied the efficacy, safety and tolerability of Technosphere inhaled insulin (MannKind Corporation) compared with Technosphere powder placebo. The researchers recruited 126 insulin-naïve patients with suboptimally controlled type 2 diabetes for participation in the double blind, placebo-controlled, multicenter, parallel group study. Inhaled insulin or powder was added to the patients’ oral antidiabetes regimen.
After 12 weeks of treatment, patients assigned to inhaled insulin experienced greater reductions in HbA1c from baseline compared with patients assigned to powder (–0.72 vs. –0.30; P=.003). Inhaled insulin users also experienced a 56% reduction in postprandial glucose excursions compared with a 43% reduction with powder.
“The significant HbA1c reductions with Technosphere insulin were clinically meaningful, especially considering the mildly elevated HbA1c at baseline (inhaled insulin, 8%; powder, 7.8%),” the researchers wrote.
Incidences of adverse events, such as cough, were low in both groups. No significant differences in hypoglycemia (P=.321) and hyperglycemia (P=.871) were reported with either formulation. Body weight remained unchanged in both groups.
“This first proof-of-concept trial demonstrated that Technosphere insulin is well-tolerated and substantially reduced HbA1c levels and meal-related glucose excursions in type 2 diabetic patients. Technosphere insulin may become an important treatment option in type 2 diabetes. Larger, long-term clinical trials are in progress to further evaluate the efficacy and safety of Technosphere insulin reported in this study,” the researchers wrote. – by Katie Kalvaitis
Diabetes Care. 2008;31:2177-2182.
Technosphere inhaled insulin is effective, useful and patient-friendly. On the other hand, will it be valuable? Time will tell. Technosphere is the third in a row of inhaled insulins. Exubera (Pfizer) was taken off the market in 2007 for lack of interest and Eli Lilly also had an inhaled insulin but investigation was stopped. All of the inhaled insulins look very effective, and would be very useful for patients who fear the needle. Adverse events are a concern, namely fibrosis, reduced pulmonary function and potential risk for cancer; I think, probably, the side effects are overrated. There is still a lot of interest in inhaled delivery of drugs and a need for more investigation remains.
– Derek LeRoith, MD, PhD
Endocrine Today Editorial Board member