PMID-25744115 – Exenatide Once Weekly DURATION-1 Five-Year Results
Henry RR, Klein EJ, Han J, Iqbal N. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin Proc. 2015;90(4):443-449.
Quick Reference
| Property | Value |
|---|---|
| PMID | 25744115 |
| DOI | 10.1016/j.mayocp.2015.01.008 |
| Year | 2015 |
| Journal | Mayo Clinic Proceedings |
| Study Type | RCT (open-label extension) |
| Evidence Level | II |
| Sample | n=295 patients with type 2 diabetes (5-year follow-up) |
| Peptide(s) Studied | Exenatide |
Key Findings
- HbA1c levels were significantly and durably reduced with a least-squares mean change of -1.6% from baseline over 5 years
- Significant improvements in fasting plasma glucose (-28.8 mg/dL from baseline)
- Sustained weight loss of -3.0 kg from baseline over 5 years
- Improvements in lipids and diastolic blood pressure maintained long-term
- Minor hypoglycemia occurred predominantly in patients using concomitant sulfonylureas
- No major hypoglycemia events observed; no new safety signals over the 5-year period
- Injection site reactions decreased over time
Study Design
Open-label extension of the 30-week DURATION-1 RCT comparing exenatide once weekly 2 mg vs. exenatide twice daily 10 mcg. After 30 weeks, all patients were transitioned to once-weekly exenatide for an additional 4.5 years of open-label follow-up. Assessments included HbA1c, fasting glucose, body weight, lipids, blood pressure, and safety.
Limitations
- Open-label extension design after initial 30-week RCT
- No placebo control group during the extension period
- Significant patient attrition over 5 years (~47% completion)
- Background medication changes were permitted, confounding attribution
- Selection bias from patients willing to continue treatment
Clinical Relevance
DURATION-1's 5-year extension provides the longest efficacy and safety data for extended-release exenatide. The sustained HbA1c reduction and weight loss demonstrate durable clinical benefits. The absence of new safety signals over prolonged use supports long-term prescribing confidence. These data remain important context for practitioners comparing first-generation (exenatide) vs. newer GLP-1 RAs (semaglutide, tirzepatide).
Related
#research #RCT #evidence-level-II #metabolic #exenatide