June 29 2010 (Orlando, Florida) — In patients with type 2 diabetes, inhaled insulin before each meal, plus insulin glargine before bedtime, is just as effective at controlling blood sugar as conventional twice-daily premixed biaspart insulin therapy, according to new research presented here at the American Diabetes Association (ADA) 70th Scientific Sessions and published in the June 26 issue of the Lancet.
The similarity in benefit comes with 2 important advantages — less weight gain and less hypoglycemia, said Daniel L. Lorber, MD, director of endocrinology and associate director of the Theresa and Eugene Lang Center for Research and Education at New York Hospital, in Queens.
Oral antidiabetes drugs can provide glycemic control early on in type 2 diabetes, but progressive beta-cell insufficiency can eventually lead to the need for insulin to lower blood sugar levels and achieve glycemic control, Dr. Lorber said. However, the use of insulin is often a delayed strategy because it is associated with weight gain, hypoglycemia, and the need for subcutaneous injections.
In this multicenter study, which enrolled patients from 10 countries, Dr. Lorber and his colleagues compared the efficacy and safety of prandial Technosphere inhaled insulin (MannKind) with twice-daily biaspart insulin.
Technosphere inhaled insulin is an ultrarapid formulation containing recombinant human insulin adsorbed onto powder that is delivered into the lungs by a small inhaler device.
The open-label parallel-group study randomized adult patients with type 2 diabetes who were poorly controlled despite insulin therapy, with or without oral antidiabetes drugs, to receive 1 year of treatment with premeal Technosphere inhaled insulin powder plus bedtime insulin glargine or twice-daily premixed biaspart insulin (70% insulin aspart protamine suspension and 30% insulin aspart of recombinant DNA origin).
The study's primary end point was change in glycosylated hemoglobin (HbA1c) from baseline to week 52.
The researchers found that changes in HbA1c were similar in both groups. The 211 patients treated with inhaled insulin glargine had a decrease of 0.68%, and the 237 treated with biaspart insulin had a decrease of 0.76%.
They also found that patients in the inhaled insulin group gained a mean of 0.9 kg, compared with 2.5 kg in the biaspart insulin group, and had fewer mild to moderate and severe hypoglycemic events than patients in the biaspart insulin group.
With regard to safety, more patients (32%, n = 103) treated with inhaled insulin plus insulin glargine reported cough than those treated with biaspart insulin (14, 4%). There were 142 events of cough reported in patients treated with inhaled insulin plus insulin glargine. Most cases (64%) were intermittent, and 34% were reported as a single episode. Most of these cough events (77%) occurred within 10 minutes of insulin inhalation and were nonproductive in 89% of the cases. Most of the coughing episodes were reported during the first week of treatment, and declined to about 2 per week by week 6.
"We believe that the use of Technosphere inhaled insulin, an ultrarapid prandial insulin, along with a basal insulin, could provide improved glycemic control with lower weight gain and rates of hypoglycemia in many individuals with type 2 diabetes," Dr. Lorber said, concluding his presentation.
Asked about the issue of cough in an interview with Medscape Diabetes, Dr. Lorber said that any inhaled powder triggers a cough in some people. "In this particular study, what you see is that many people cough once within a few minutes of their first inhalation. But that, in the adverse event (AE) recording, is recorded as 'cough being an AE,' which is why the vast majority of the AEs were cough. In terms of cough causing people to stop the drug, those numbers were very small."
Technosphere inhaled insulin would be particularly useful in 2 scenarios — in people with type 1 diabetes and in insulin-naïve people with type 2 diabetes, Dr. Lorber said.
"The smaller [group] would be the type 1 population, who would use it at mealtimes. It's a small inhaler device; it's quick and easy to use and it's very unobtrusive, particularly if you are out for dinner and don't want to take a pen out and go through the whole process of [an injection]. It's much less obtrusive to take this little inhaler out — it's the size of a large thumb — and just inhale something," he said. "The bigger population is obviously the type 2 population, who says 'Doc, anything but the needle. Don't give me the needle, whatever you do.' Studies need to be developed to look at using this in lieu of injectable insulin in those people."
Sue Kirkman, MD, vice president of clinical affairs at the ADA, who moderated the session at which Dr. Lorber presented his data, gave Medscape Diabetes her opinion of the study, stressing that it was her own and not that of the ADA.
"Inhaled insulin was something clinicians and patients first looked to with great excitement, but that has been somewhat tempered because of the side effects. The initial inhaled insulin was cumbersome to use and was not really seen as more convenient than injections for a lot of patients. That being said, I think that Technosphere insulin appears to be easier to use."
She cautioned that Technosphere inhaled insulin will need much more study. "It will be interesting to see how this product plays out. Because of the problems we've seen with the other product and the question about lung cancer and all that, it's just going to need a lot of long-term scrutiny, like any other new drug."
This study was funded by MannKind. Dr. Lorber has reported financial relationships with Merck & Co, Inc., Novo Nordisk Inc, Biodel Inc., GlaxoSmithKline, Johnson & Johnson, and Roche Pharmaceuticals. Dr. Kirkman has disclosed no relevant financial relationships.
American Diabetes Association (ADA) 70th Scientific Sessions: Presented June 26, 2010.
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Cite this: Inhaled Insulin Rivals Conventional Insulin Therapy for Type 2 Diabetes - Medscape - Jun 29, 2010.