Comparable results for HbA1c levels and hypoglycaemia
Regarding the lowering of blood glucose levels, exenatide was superior to placebo and not inferior to insulin therapy: on average, patients treated with exenatide or insulin achieved a reduction in HbA1c levels of about 1%. The rate of severe hypoglycaemic episodes with exenatide was also comparable to the rates in both the placebo-controlled and the active controlled studies (with insulin aspart and insulin glargine).
More adverse events with exenatide
Regarding adverse events, the performance of exenatide was clearly poorer than that of placebo or insulin: patients who injected exenatide suffered more frequently from nausea, vomiting, or diarrhoea, and also discontinued the study more frequently due to adverse events. In patients receiving exenatide, the rate of adverse events and study discontinuations was dose-dependent.
Exenatide improves weight control
In all studies, patients in the exenatide groups were able to lose weight. They were slightly more successful than patients in the placebo groups. In contrast, patients in the insulin groups put on weight. In the active-controlled studies, the mean difference between exenatide and insulin, depending on study duration, was 4.1 kg at Week 26 (insulin glargine) and 5.5 kg at Week 52 (insulin aspart). However, it remains unclear what health effects the improvement in weight control have. Indications exist of a blood-pressure lowering effect. It is also unclear whether this leads to an additional benefit for patients by reducing the rate of late complications of diabetes type 2.
No robust data on quality of life and treatment satisfaction
Data on patients' health-related quality of life and treatment satisfaction were collected in both active-controlled studies, but have so far only been published for the clinical comparison
|Contact: Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care