Subanalyses of Elderly Type 2 Diabetes Patients or Type 2 Diabetes Patients With Renal Impairment
Status:
Completed
Trial end date:
2015-08-01
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 in patients with mild and moderate renal impairment and in elderly
patients are 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 among elderly
patients and patients with renal impairment. 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. Changes in HbA1c, weight, markers for renal function (estimated
glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR)), and
incidences of gastrointestinal symptoms and hypoglycaemia are investigated for patients with
different eGFR categories and with different ages.