drugset / Trial / NCT01003184

Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes

NCT01003184 ↗

Phase 3 Completed 222 enrolled AstraZeneca Eli Lilly and Company · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes.

Timeline

Start
2009-10
Primary completion
2011-07
Completion
2011-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Exenatide Once Weekly vs Insulin Detemir; p <.0001; Odds Ratio (OR) 6.60 (95% CI 3.17 to 13.73); Regression, Logistic NCT01003184 ↗

release “In the study, 44.1 percent of patients receiving BYDUREON, compared with 11.4 percent of those treated with insulin detemir, met the primary composite endpoint” alkermes.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Exenatide Peptide 2 mg Subcutaneous
Comparator insulin detemir Protein / enzyme biologic — Subcutaneous