drugset / Trial / NCT01928329

A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes

NCT01928329 ↗

Phase 2 Completed 79 enrolled Yale University
RandomizedParallel-groupTriple-blindTreatment

Summary

The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D)

Timeline

Start
2013-09
Primary completion
2018-06
Completion
2019-08

Outcome

Missed primary endpoint

registry analysis (superiority test); Exenatide (Bydureon) vs Placebo; p = 0.0816; Mean Difference (Final Values) -0.23 (95% CI -0.50 to 0.03) NCT01928329 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Exenatide Peptide 2 mg Subcutaneous