Exenatide reduced HbA1c with no weight gain and no increased incidence of hypoglycemia in patients with type 2 diabetes failing to achieve glycemic control with Metformin.

Exenatide is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics, and exhibits many of the same effects as the human incretin hormone GLP-1 ( Glucagon Like Peptide – 1) .

A 30-week study evaluated the ability of the Exenatide ( Exendin-4 ) to improve glycemic control in patients with type 2 diabetes failing to achieve glycemic control with maximally effective Metformin doses.

A total of 336 randomized patients were enrolled.
In all, 272 patients ( mean age 53 years; mean BMI 34.2 kg/m2; mean HbA1c 8.2% ) completed the study.

After 4 weeks of placebo, patients self-administered 5 µg Exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 µg Exenatide, or placebo subcutaneously twice daily for 26 weeks.
All patients continued Metformin therapy.

Of evaluable patients, 46% of those who received 10 µg Exenatide twice daily achieved an HbA1c of 7% or less. The mean HbA1c at baseline was 8.2%.

The patients treated with Exenatide showed progressive dose-dependent mean weight loss : -2.8 kg in the 10 µg group, and -1.6 kg in the 5 µg.

Exenatide was well tolerated. Nausea was the most common reported effect.
Incidence of mild to moderate hypoglycemia was low and similar between active treatment and placebo groups, with no severe hypoglycemia.

Source: Diabetes Care, 2005


XagenaMedicine2005