drugset / Trial / NCT00360334
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.
Timeline
- Start
- 2006-06
- Primary completion
- 2008-04
- Completion
- 2008-04
Outcome
Met primary endpoint
registry NUMBER Exenatide: 53.4 percentage of participants NCT00360334 ↗
registry analysis (superiority or other test); Exenatide vs Insulin Glargine; p <0.001; Odds Ratio (OR) 4.71 (95% CI 2.62 to 8.46); Regression, Logistic NCT00360334 ↗
Publications
- Results Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab. 2009 Dec;11(12):1153-62. doi: 10.1111/j.1463-1326.2009.01154.x.
- Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | 5 ug | Subcutaneous |
| Subject | Exenatide | Peptide | 10 ug | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |