Introduction: The objective of this study was to determine whether the addition of twice-daily exenatide injections caused a greater HbA1c reduction than placebo in people receiving insulin glargine for the treatment of type 2 diabetes.
Methods: In this 30 week, parallel, randomized, placebo-controlled trial, exenatide (at 10 mcg/day) or placebo were added to insulin glargine alone or in combination with oral medications (metformin or pioglitazone, alone or in combination).
Results: The results showed that HbA1c levels decreased more in the exenatide than placebo group (-1.74% vs. -1.04%, respectively). Moreover, there was a significant weight decrease of -1.8 kg with exenatide vs. an increase in weight of 1 kg in the placebo group. Finally, the exenatide group required lower insulin doses than the placebo group (13 units/day vs. 20 units/day, respectively), and there was no difference in the rate of hypoglycemia between the 2 groups.
Commentary by Grazia Aleppo MD, FACE, FACP
This study was chosen because it is the first study to show that adding exenatide to insulin glargine-treated patients who are also on oral hypoglycemic medications causes a greater reduction of HbA1c. This study also shows that adding exenatide causes weight loss instead of weight gain and that patients treated with exenatide and insulin glargine need lower daily insulin requirements compared to placebo.
The use of exenatide in addition to insulin has now been approved by the FDA.