Combining exenatide with insulin may be 'best result ever' for diabetes patients, study suggests

"This study may be the best result ever for patients whose diabetes is inadequately controlled on a combination of pills and insulin," said John Buse, MD, PhD, lead author of the study and chief of the Division of Endocrinology and Metabolism in the University of North Carolina at Chapel Hill School of Medicine.

"Until now, it was inconceivable that you could get such patients under excellent control with weight loss and no significant problems with hypoglycemia," Buse said.

Type 2 diabetes is a devastating disease, a leading contributor to blindness, amputations, kidney failure, heart attack, stroke and even cancer. But the most powerful diabetes drug, a formulation of insulin called Lantus, is associated with weight gain and low blood sugar reactions that may limit the success of more intensive treatment.

Exenatide (brand name: Byetta) is a newer diabetes drug whose active ingredient was first discovered in the saliva of the Gila monster, a large lizard from the Arizona desert. "It has the advantages of not leading to low blood sugar and in fact promotes weight loss," Buse said.

"Because Byetta and Lantus have very different strengths, we thought that combining the two had the potential to give us the best of both. It is wonderful, when you guess right."

The study was published online on Dec. 7, 2010 by the Annals of Internal Medicine and will appear in the Jan. 18, 2011 print issue of the journal.

The 30-week study was conducted at 59 centers in five countries (Greece, Israel, Mexico, the U.K. and the U.S.) with 261 participants. All were adults with type 2 diabetes who were taking once-daily injections of Lantus, either alone or with diabetes pills. They were randomly assigned to receive twice-daily injections of Byetta or placebo in addition to the diabetes medications that they were taking.

Among the 138 patients on Byetta, 60 percent achieved near normal blood sugar levels, compared to 35 percent of those on placebo. Byetta recipients also lost an average of four pounds during the study while placebo recipients gained an average of two pounds. There were no differences in the rates of hypoglycemia between the two groups.

Byetta recipients reported side effects more frequently than placebo recipients, particularly nausea, vomiting and diarrhea, but only in 10 percent of cases were the side effects bad enough to cause patients to stop the drug.

The study was funded and sponsored by an alliance of Eli Lilly and Company and Amylin Pharmaceuticals, who are collaborating to market Byetta.

In addition to Buse, authors of the study are Richard M. Bergenstal, MD; Leonard C. Glass, MD; Cory R. Heilmann, PhD; Michelle S. Lewis, PhD; Anita Y.M. Kwan, MS; Byron J. Hoogwerf, MD; and Julio Rosenstock, MD.