Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
The glucagon-like peptide 1 (GLP-1) agonist exenatide represents an effective therapy in
patients with type 2 diabetes mellitus (T2DM), which also seems to have some important
non-glycemic effects. Yet, these non-glycemic effects are still largely unknown.
The effect of exenatide once weekly was investigated in controlled, blinded and open-label
clinical studies in subjects with T2DM who were controlled on diet and exercise alone or in
combination with oral antidiabetic agents, but also in multi-dose controlled studies and such
studies resulted in significant reductions in glycemic parameters (mean glycated hemoglobin
(HbA1c), fasting serum/plasma glucose as well as postprandial plasma glucose levels), but
also in body weight, over 24 to 30 weeks. Meaningful reductions were observed as early as
week 4 of treatment, and maintained through 6 years of treatment.
The study investigating cardiovascular effects of exenatide once weekly is currently
undergoing. The results available are not numerous (such as DURATION-2, DURATION-3,
DURATION-4 studies) and cannot lead to definitive conclusions.
In this study the investigators will evaluate the effect of exenatide once-weekly on multiple
cardiovascular risk markers. These markers are related to subclinical atherosclerosis,
endothelial dysfunction, oxidative stress and atherogenic lipoproteins.
The investigators will perform an open label, single-arm, prospective, intervention study
using exenatide once weekly for a period of 8 months on 60 patients with T2DM.