A Phase 2 interventional study of exenatide and Insulin in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 5 sites in United States. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-02-23.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).
This is an exploratory, multicenter, open-label, 2-arm, parallel trial. Approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy, will be randomized to discontinue insulin and substitute it with exenatide or remain on their current diabetes therapy regimen. All patients will continue their current diet and exercise regimen during the study.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 49 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy.
Drug: exenatide
The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.
Drug: Insulin
Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.
Also known as: synthetic exendin-4, AC2993, Byetta
Insulin will be taken according to the subject's current regimen
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16
Change in HbA1c from Baseline study termination (Week 16)
Time frame: Baseline, Week 16
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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AstraZeneca