ADA: Inhaled Insulin Makes a Comeback for Type 2's

The similarity in benefit comes with two 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 HbA_1c from baseline to week 52.

The researchers found that changes in HbA_1c 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.

Technosphere inhaled insulin would be particularly useful in two 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."

The Lancet. 2010;375:2244-2253. American Diabetes Association (ADA) 70th Scientific Sessions: Presented June 26, 2010.