drugset / Trial / NCT00935532
Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
RandomizedParallel-groupOpen-labelTreatment
Summary
The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.
Timeline
- Start
- 2009-07
- Primary completion
- 2010-09
- Completion
- 2011-07
Outcome
Met primary endpoint
registry Exenatide Once Weekly vs Insulin Glargine; p <.001; Least Squares Mean Difference -0.43 (95% CI -0.59 to -0.26) NCT00935532 ↗
paper Exenatide QW was statistically noninferior to insulin glargine for the change in HbA(1c) from baseline to end point PMID 22884767 ↗
Publications
- Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
- Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T. Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study. Clin Ther. 2012 Sep;34(9):1892-908.e1. doi: 10.1016/j.clinthera.2012.07.007. Epub 2012 Aug 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | 2 mg | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 4 iu | Subcutaneous |