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Exenatide plus basal insulin further improved glycemic control, weight loss
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Combining insulin glargine and twice-daily injections of exenatide improved glycemic control and was associated with moderate weight loss in adults with type 2 diabetes.
In a company-sponsored study, researchers found that HbA1c levels decreased by 1.74% in patients with type 2 diabetes who were assigned exenatide (Byetta; Amylin, Eli Lilly) and insulin glargine (Lantus, Sanofi-Aventis) vs. 1.04% in those receiving placebo (95% CI, –0.93 to –0.46). Exenatide patients also experienced a 1.8-kg weight loss, whereas patients in the placebo group gained 1 kg (95% CI, –3.7 to –1.7).
Rates of hypoglycemia did not differ significantly between groups, according to the results.
“This study may be the best result for patients whose diabetes is inadequately controlled on a combination of pills and insulin,” John Buse, MD, PhD, study researcher and chief of the division of endocrinology and metabolism in the University of North Carolina at Chapel Hill School of Medicine, said in a press release. “Until now, it was inconceivable that you could get such patients under excellent control with weight loss and no significant problems with hypoglycemia.”
Study design, data
For 30 weeks, the researchers randomly assigned adults with type 2 diabetes whose HbA1c levels were between 7.1% and 10.5% to receive two 10-mcg daily injections of exenatide or placebo in addition to insulin glargine. Patients who were using metformin and pioglitazone (Actos, Takeda) also warranted inclusion. One hundred twelve patients in the exenatide group and 101 patients in the placebo group completed the study.
Although insulin dosage escalated from baseline in both groups, this increase was more pronounced in patients receiving placebo (20 unit per day) than in those receiving exenatide (13 units per day; 95% CI, –12.3 to –0.8), the researchers said. Self-monitoring blood glucose also appeared lower at nonfasting time points and morning and evening postprandial glucose excursions (P<.001).
Patients in the exenatide arm, however, also experienced more adverse events than those receiving placebo, including nausea, diarrhea, vomiting, headache and constipation.
Interpretations
In an accompanying editorial, David M. Nathan, MD, of Massachusetts General Hospital in Boston, said there is a need for more diabetes drugs, but this trial does not yield sufficient data on the medication’s efficacy compared with other treatments. He also cited the study’s duration as a drawback.
“The study was only 30 weeks in duration, limiting its applicability to a chronic disease in which drug effects are important over decades, not months,” Nathan wrote. “Long-term comparative effectiveness studies are needed to determine the best treatment approaches for the ongoing epidemic of type 2 diabetes, which shows no sign of relenting.” – by Melissa Foster
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Dr. Buse has no direct financial interest in any of the products mentioned in this article nor is he a paid consultant for any of the companies mentioned.
Dr. Nathan has no direct financial interest in any of the products mentioned in this article nor is he a paid consultant for any of the companies mentioned.
Both pharmaceutical companies and the FDA prefer placebo-controlled trials to studies which compare the efficacy of a drug to that of another medication. In many cases, this leads to prolonged poor glycemic control, which has the potential to be harmful. Why did this study not compare exenatide to twice- or three-times daily fast-acting insulin analogs added to basal insulin? The study would probably have shown better postprandial glucose levels, less hypoglycemia, weight loss and comparable HbA1c levels with exenatide. However, the risk that this would not be shown was probably more than the sponsors could tolerate.
– David S. H. Bell, MD, FACE, FACP
Endocrine Today Editorial Board member
Dr. Bell has no direct financial interest in any of the products mentioned in this article nor is he a paid consultant for any of the companies mentioned. He is a consultant and speaker for Novo Nordisk.
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