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Investigators examining whether exenatide (Byetta, Amylin/Lilly) can be used as an alternative to basal insulin glargine (Lantus, Sanofi-Aventis) in type 2 diabetes found it achieves similar improvements in glycemic control in patients also treated with metformin and a sulfonylurea.
Robert J. Heine, MD, PhD, of VU University Medical Center in the Netherlands, presented the findings September 12 at the 41st Annual Meeting of the European Association for the Study of Diabetes in Athens, Greece. Eli Lilly and Amylin Pharmaceuticals sponsored the research, which also was published in Annals of Internal Medicine.1
The 26-week, 13-nation trial randomized 549 patients with type 2 diabetes to receive fixed-dose exenatide (5 µg the first 4 weeks; 10 µg for the next 22 weeks) or titrated insulin glargine in addition to their existing regimens of metformin and a sulfonylurea. Baseline glycated hemoglobin (A1C) was 8.2% for the exenatide patients and 8.3% for the glargine patients. After 26 weeks, both groups achieved an average 1.1% A1C reduction.
The proportion of patients meeting target A1C
7% was similar in each
group (46% for exenatide and 48% for glargine). Glargine lowered fasting
glucose more than twice as much as exenatide (2.9 mmol/l and 1.2
mmol/l, respectively). Exenatide reduced postprandial glucose excursions,
while glargine did not. And exenatide resulted in a 2.3-kg (5.1-lb) loss in
body weight compared with a 1.8-kg (4-lb) weight gain for patients on
glargine. Rates of symptomatic hypoglycemia were similar in the two treatment
groups, but nocturnal hypoglycemia was less frequent with exenatide and
daytime hypoglycemia was less frequent with glargine.
Withdrawals due to adverse events were 9.5% of the exenatide group and 0.7% of the glargine group. Mild to moderate nausea that progressively diminished was the most common adverse effect reported in the exenatide group.
"These results support use of exenatide prior to the addition of a starter basal insulin for type 2 diabetes suboptimally controlled on oral agents," Heine says.
In an editorial, Richard Comi, MD, notes that achieving glucose control without weight gain on exenatide suggests "a real advance in managing the later stages of diabetes."2
One attendee pointed out that exenatide has not been shown to lower A1C
beyond 8%, which he called "still very poor control."
References
2. Comi RJ: Treatment of type 2 diabetes: A weighty enigma.
Ann Intern Med 143:609610, 2005.
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