June 24, 2010 -- Inhaled insulin proved to be as effective at lowering blood sugar levels as standard insulin injection treatment, and with minimal side effects, among patients with uncontrolled type 2 diabetes, according to a new study.
Reporting in this week's American Diabetes Association meeting and in The Lancet, researchers compared two approaches to managing type 2 diabetes among patients ages 18 to 80 from 10 different countries. The patients were nonsmokers and had poor control of blood sugar despite insulin therapy.
A total of 211 patients received inhaled insulin plus insulin glargine, a long-lasting form of insulin taken by injection, before bedtime to help manage blood sugar. They were compared with a comparison group of 237 patients who did not use the inhaler, but received insulin injections instead.
One year after treatment, the researchers found that:
- Blood sugar levels were similar in the two groups; 22% of patients in the inhaled insulin/insulin glargine group reached a goal A1c level of 7% or less while 27% of those solely on insulin injections reached the goal.
- Patients using the inhaler gained less weight -- a major concern among diabetes patients. The inhaler group gained only an average of about 2 pounds, whereas the control group gained an average of about 5.5 pounds.
- Patients using the inhaler had fewer episodes of hypoglycemia -- a sudden drop in blood sugar -- than those in the comparison group, occurring in 31% of patients on inhaled insulin/insulin glargine group vs. 49% of those in the insulin injection group.
- Patients using the inhaler reported more side effects with coughing and upper respiratory infections. Most of the coughing occurred within the first 10 minutes of inhalation and primarily during the first week of treatment and declined as treatment continued.
- Prior use of metformin, an oral drug commonly taken to manage blood sugar, did not affect results among the two groups of patients.
"Our findings show that inhaled insulin plus insulin glargine, alone or in combination with an oral antidiabetes drug such as metformin, is an effective alternative to conventional insulin therapy (biaspart insulin) in uncontrolled type 2 diabetes," study researcher Julio Rosenstock, MD, and colleagues write. "Inhaled insulin ... could provide improved blood sugar control with lower weight gain and rates of hypoglycaemia in many individuals with type 2 diabetes."
Search for New Ways to Manage Diabetes
This research was funded by MannKind Corp., a California-based biopharmaceutical company that manufactures Technosphere, the inhaler device used to deliver the insulin in this study. MannKind is using Technosphere to administer an inhaled insulin drug called Afreszza, which has not yet been approved by the FDA.
There is a great deal of interest among drug companies and patients in finding new ways to better manage diabetes. According to the American Diabetes Association, nearly 8% of the U.S. population has either type 1 or type 2 diabetes. There are 1.6 million new cases of diabetes diagnosed in people aged 20 and older every year.
In an accompanying editorial, British researchers Clifford J. Bailey, MD, from Aston University and Birmingham Children's Hospital, and Anthony H. Barnett, MD, from the Heart of England NHS Foundation Trust and the University of Birmingham, suggest that more research is needed to flesh out any possible safety issues with using inhaled insulin, particularly concerns over how inhaled insulin affects the alveoli -- tiny air sacs in the lungs.
They conclude: "The opportunity for convenient inhaled bolus insulin, to facilitate complex insulin delivery regimens, will be welcomed by some patients. For now, we say: proceed with caution."
Inhaled insulin was recently introduced to the U.S. market when Exubera, manufactured by the New York-based pharmaceutical corporation Pfizer, was approved by the FDA in 2006. However, Pfizer discontinued Exubera the following year due to poor sales.