drugset / Trial / NCT02455076

Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes

NCT02455076

Phase 4 Completed 150 enrolled Emory University
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to try and achieve similar glycemic control in general non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes with exenatide alone or in combination with basal insulin as compared to treatment with basal bolus insulin alone. The association between hyperglycemia and poor clinical outcomes in patients with diabetes is well established. Previous studies have shown that basal bolus insulin regimens improve glycemic control and reduce the rate of hospital complications compared to sliding scale regular insulin (SSRI) therapy, but has a significant risk of hypoglycemia. The investigators will compare the efficacy and safety of exenatide alone or in combination with basal insulin to control high blood glucose levels resulting in a lower risk of hypoglycemia.

Timeline

Start
2015-09
Primary completion
2018-03
Completion
2018-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Exenatide Peptide 10 ug Subcutaneous
Comparator insulin glargine Protein / enzyme biologic