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NCT02974244 · ClinicalTrials.gov registry record
Comparison of the Effectiveness and Tolerability of Exenatide Once-weekly Compared to Basal Insulins
A clinical trial, sponsored by AstraZeneca.
- Completed
- Registry status
- 7,000
- Enrollment target
NCT02974244: Completed study, sponsored by AstraZeneca.
NCT02974244 is a clinical trial that has completed, run by AstraZeneca. The registered enrollment target is 7,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02974244 has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 7,000 participants
- Enrollment target
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.
Primary Outcome
To evaluate changes in HbA1c from baseline one year after starting treatment with exenatide once weekly and basal insulin
Interventions
- DRUG basal insulin
- DRUG exenatide once weekly
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,000 participants |
| Start Date | 2014-10-28 |
| Est. Completion | 2014-10-28 |
What the finished NCT02974244 record still lists
NCT02974244 is an observational study that tracks outcomes without assigning an intervention. Its 7,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which basal insulin is the first listed.
NCT02974244 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02974244 about?
NCT02974244 is a clinical study titled "Comparison of the Effectiveness and Tolerability of Exenatide Once-weekly Compared to Basal Insulins". 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 g...
What is the current status of trial NCT02974244?
This trial is currently completed. The enrollment target is 7,000 participants. The study started on 2014-10-28. Estimated completion is 2014-10-28.
What interventions are being tested in trial NCT02974244?
The interventions under investigation include: basal insulin (DRUG), exenatide once weekly (DRUG).
Who is sponsoring clinical trial NCT02974244?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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