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Does Adding Exenatide to Insulin Treatment Benefit Patients With Type 2 Diabetes? FREE

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The full report is titled “Use of Twice-Daily Exenatide in Basal Insulin–Treated Patients With Type 2 Diabetes. A Randomized, Controlled Trial.” It is in the 18 January 2011 issue of Annals of Internal Medicine (volume 154, pages 103-112). The authors are J.B. Buse, R.M. Bergenstal, L.C. Glass, C.R. Heilmann, M.S. Lewis, A.Y.M. Kwan, B.J. Hoogwerf, and J. Rosenstock.

Ann Intern Med. 2011;154(2):I-40. doi:10.7326/0003-4819-154-2-201101180-00301
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What is the problem and what is known about it so far?

Type 2 diabetes mellitus interferes with the body's ability to store energy from food, resulting in high blood sugar levels that can lead to kidney failure, blindness, and heart disease. Insulin helps the body convert food to stored energy and keeps blood sugar levels within the normal range. In type 2 diabetes, body tissues are resistant to the effects of insulin and patients lack effective insulin levels required to keep their blood sugar levels normal. Prescription pills and, if needed, insulin injections can help some patients. However, sugar levels may remain high despite these treatments.

An injectable medication called exenatide may benefit these patients. Exenatide triggers an increase in insulin secretion, which helps reduce blood sugar levels. It also slows digestion and leads to a decrease in food intake, leading to weight loss, unlike many diabetes medications that cause weight gain.

Why did the researchers do this particular study?

Research on the benefits and harms of combining exenatide with insulin in patients with type 2 diabetes was sparse.

Who was studied?

261 adults with type 2 diabetes who were taking long-acting, once-daily insulin (glargine) alone or with diabetes pills (metformin or pioglitazone); had a body mass index less than the cutoff for extreme obesity (45 kg/m2 or less); and had a hemoglobin A1c (HbA1c) level of 7.1% to 10.5%. Hemoglobin A1c is a blood test that measures blood sugar control over the previous 3 months. Lower levels mean better control, and the recommended target is less than 7%.

How was the study done?

Participants were randomly assigned to receive exenatide or placebo injections twice daily plus insulin glargine and, if they were already taking them, diabetes pills. In both groups (exenatide and placebo), insulin treatment was optimized by increasing or decreasing the dose to try to achieve fasting blood sugar targets.

What did the researchers find?

Exenatide treatment resulted in greater decreases in blood sugar levels; 60% of participants receiving exenatide achieved normal HbA1c levels compared with 35% of those receiving placebo. Exenatide recipients needed smaller increases in their insulin dose than placebo recipients. Exenatide recipients lost an average of 4 pounds, whereas placebo recipients gained an average of 2 pounds. Nausea (41% vs. 8%), diarrhea (18% vs. 8%), vomiting (18% vs. 4%), headache (14% vs. 4%), and constipation (10% vs. 2%) were increased with exenatide compared with placebo, but episodes of hypoglycemia were similar between groups.

What were the limitations of the study?

Of the 138 patients who received exenatide, 13 stopped treatment because of undesired adverse effects. The study was only 6 months long; longer-term effects of combining exenatide with insulin treatment remain unknown.

What are the implications of the study?

Adding exenatide to insulin glargine treatment can help decrease blood sugar levels in patients with uncontrolled type 2 diabetes and can lead to modest weight loss. However, the adverse effects and need for injection may be intolerable for some patients.





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