The study, presented by Tibor Ivanyi, MD, of Eli Lilly and Company, Hungary, was a retrospective evaluation of safety and efficacy data from three clinical trials comparing the incretin mimetic exenatide and insulin in patients with type 2 diabetes.

Trial A was a 26-week parallel group trial in 549 patients treated with metformin and sulfonylurea. Trial B was a two-period, 16-week crossover study in patients treated with metformin or sulfonylurea (n=114). Trial C was a 52-week parallel-group trial in patients treated with metformin and sulfonylurea (n=501).

Exenatide was administered as a fixed 10 mcg dose BID, and insulin was titrated regularly and administered QD (insulin glargine) or BID (biphasic insulin aspart).

Efficacy endpoints included changes in body weight, haemoglobin A1c (HbA1c), fasting and postprandial glucose, and lipid profile. Rates of hypoglycaemia and other adverse events were also compared between treatment groups.

An analysis of the results showed that exenatide reduced HbA1c levels in the range of -1.0 to -1.4%, which was comparable to changes seen in response to insulin (-0.9 to -1.4%).

The researchers noted, however, that there was a difference in the method of action between the two drugs in that exenatide produced greater reductions in postprandial glucose than insulin did, while insulin reduced fasting glucose to a greater extent, compared with exenatide.

Moreover, there was a differential effect between the two drugs with respect to their effects on body weight. Namely, the use of exenatide resulted in a reduction of weight in the range of -1.8 to -2.5 kg, while subjects receiving insulin experienced weight gains of 0.5 to 2.9 kg.

Rates of hypoglycaemia were similar between the treatment groups in each trial. Nausea and vomiting were more common with exenatide. However, the researchers pointed out that the body weight reductions observed in patients receiving exenatide were not significantly associated with nausea and vomiting.

According to the investigators, these results indicate that, "Exenatide may be an appropriate alternative to insulin therapy, particularly when patient body weight is an important clinical consideration."

The study was funded by Eli Lilly and Company and Amylin Pharmaceuticals, Inc.


[Presentation title: Exenatide Provides HbA1c Reductions Comparable to Insulin With the Additional Effect of Weight Reduction. Abstract T3:PO.137]

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