drugset / Trial / NCT01003184
Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | 2 mg | Subcutaneous |
| Comparator | insulin detemir | Protein / enzyme biologic | — | Subcutaneous |