ADA 2010: Exenatide beats insulin glargine in glycated hemoglobin, weight control

June 28, 2010

Patients who are not well controlled on metformin may get better control of glycated hemoglobin levels and weight using once-weekly exenatide than by titrating insulin glargine.

Patients who are not well controlled on metformin may get better control of glycated hemoglobin levels and weight using once-weekly exenatide than by titrating insulin glargine.

That is the clinical message from a trial reported Saturday morning during a special symposium cosponsored by ADA and The Lancet, which published the study on June 26.

“We clearly need to control glucose,” said lead author Michaela Diamant, MD, associate professor of endocrinology and scientific director, Diabetes Centre, VU University Medical Centre, Amsterdam, The Netherlands. “We also need to consider weight gain, avoid hypoglycemia, and most important, convenience to the patient so they actually use the treatment.”

Diamant and researchers in the United States, the European Union, Korea, Taiwan, Mexico, and Russia randomized 456 patients taking metformin with poorly controlled glycated hemoglobin to once-weekly exenatide (233 patients) or self-titrated insulin glargine (223 patients) for 26 weeks.

Diamant noted that it is impossible to blind the 2 drugs, a weekly abdominal injection of exenatide versus daily insulin injection. The trial was open label, but data analyzers were blinded. The sponsors, Amylin and Eli Lilly, were involved in study design; protocol development; collection, review, and analysis of data; and writing the published report. A 2.5-year, open-label, continuation study is underway.

Exenatide showed significantly better glycated hemoglobin lowering than insulin at 8 weeks, Diamant reported. The advantage continued through the end of the trial-a 1.5% reduction for exenatide versus 1.3% for insulin glargine (P=.017).

More exenatide patients reached an glycated hemoglobin goal of under 7% (60% vs 48%; P=.10). Exenatide was also superior at reducing glycated hemoglobin below 6.5% (35% vs 23%; P=.004).Exenatide produced a mean weight loss of 2.6 kg at week 26 compared with a 1.4-kg weight gain for insulin glargine, a difference of 4 kg (P1c and weight loss, whereas 63% of the insulin glargine group had an glycated hemoglobin reduction and weight gain. There was no difference in weight gain or loss or glycated hemoglobin reduction on the basis of baseline body mass index.

“Exenatide gave superior A1c reduction and weight loss,” Diamant concluded. “If we consider convenience and weight, it is important to consider once-weekly exenatide for our patients.”