Comparison of the Effectiveness and Tolerability of Exenatide Once-weekly Compared to Basal Insulins
Status:
Completed
Trial end date:
2014-10-28
Target enrollment:
Participant gender:
Summary
Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment
of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves
glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as
necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages,
such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid
profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes
in customary clinical care is unknown.
The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative
to basal insulin initiated as first-ever injectable therapeutic regimens used in customary
clinical care. Patients who initiated treatment with Bydureon or basal insulin between July
2011 and March 2015 will be recruited into the study cohorts from Optum's database of
electronic health records. The two treatment cohorts will be matched by propensity score
method.Clinical outcomes of HbA1c, weight, and gastrointestinal symptoms and hypoglycemia are
investigated.