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Comparison of the Effectiveness and Tolerability of Exenatide Once-weekly Compared to Basal Insulins

NCT02974244 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7000

Last updated 2017-03-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

exenatide once weekly

exenatide treatment in the customary clinical care in the USA

DRUG

basal insulin

basal insulin treatment in the customary clinical care in USA

Sponsors & Collaborators

Principal Investigators

  • Anita M Loughlin, Ph.D · Optum, Inc.

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-28
Primary Completion
2014-10-28
Completion
2014-10-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02974244 on ClinicalTrials.gov