Comparison of the Effectiveness and Tolerability of Exenatide Once-weekly Compared to Basal Insulins
Completed
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT02974244
- Run by
- AstraZeneca
- People needed
- 7000
- Starts
- 2014-10-28
- Expected to finish
- 2014-10-28
- Last updated by the study team
- 2017-03-29
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 18 years old;
- had received care documented in Electronic Health Records (including at least one out-patient provider visit) for a minimum of 6-months prior index date;
- had at least one diagnosis of type 2 diabetes by The International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM: 250.X0 or 250.X2) prior to and including the date of the study drug initiation, with no prior diagnosis of type1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
- No evidence of prior injectable antidiabetic treatment, specifically no dispensing of a GLP-1RA or any insulin during the 6-months baseline period prior to study drug initiation
You may not qualify if…
- Prior diagnosis of type1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
- Prior dispensing of a GLP-1RA or any insulin
Where it is running
- Optum Epidemiology — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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