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EASD: Adding Incretin to Insulin Lowers HbA1c

Posted: Sunday, October 03, 2010

Adding exenatide to insulin glargine for patients who aren't fully controlled with insulin glargine and/or other oral agents can help to improve their blood glucose.

According to Richard Bergenstal, MD, of the University of Minnesota, and colleagues, after six months patients taking exenatide twice daily had significantly greater improvements in A1c than those on placebo (P<0.001).

"In patients with longstanding Type 2 diabetes not ideally controlled on oral agents and insulin glargine, the addition of exenatide ... followed by continued optimization of insulin glargine, showed greater improvements in A1c," said Bergenstal, who is also president of the American Diabetes Association. He added that there was no increased risk of hypoglycemia.

This is the first trial using a GLP-1 receptor agonist with basal insulin, a combination that is not yet approved in the United States or Europe.

The researchers assessed a total of 259 patients with a mean age of 59 who were taking insulin glargine and other oral agents. They were randomized to receive either 10 mcg of exenatide twice a day or placebo, in addition to their insulin.

Insulin was titrated throughout the study to optimize fasting glucose. The primary endpoint was change in HbA1c after six months. The researchers found that by the end of the study period, A1c decreased by 1.71% with exenatide, compared with 1% for those on placebo (P<0.001).

Postprandial glucose was also improved for those on exenatide. Values of 1,5-AG, a marker of glucose after a meal (the higher the value, the lower the glucose level), were significantly higher for those on the drug compared with placebo (P=0.003).

Fasting glucose wasn't different between groups, but non-fasting, self-monitored blood sugar decreased more in the exenatide group compared with placebo (P=0.039).

Patients lost weight on the drug, dropping a mean 1.78 kg. On the other hand, those in the placebo group gained a mean of 0.96 kg (P=0.011).

Bergenstal noted that the observed weight loss was "interesting" because it "showed a significant and steady reduction in weight over the course of the trial despite insulin therapy," which is surprising since patients tend to gain weight on insulin. However, the insulin dose increased more among those on placebo (P=0.026).

There were significantly more of the expected side effects in the exenatide group, mainly gastrointestinal upset (P<0.05). "Nausea is typical at the beginning, but most people did get used to it," he said. There were no differences in the rate of hypoglycemia, and only two severe hypoglycemic events occurred in the placebo group -- in the same patient overnight.
Practice Pearls:

    * Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.

    * Explain to interested patients that giving exenatide (Byetta) to patients who aren't fully controlled with insulin glargine and other oral agents improves their blood glucose.

Source:, Bergenstal RM, et al "Exenatide added to insulin glargine-treated patients with Type 2 diabetes provided excellent fasting and postprandial control with weight loss and no increased risk of hypoglycaemia" EASD 2010; Abstract 73.

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