(Clinical Trials Registry No; NCT 00637273)
DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide
Article first published online: 16 MAY 2011
© 2011 Amylin Pharmaceuticals, Inc. Diabetic Medicine © 2011 Diabetes UK
Volume 28, Issue 6, pages 705–714, June 2011
How to Cite
Wysham, C., Bergenstal, R., Malloy, J., Yan, P., Walsh, B., Malone, J. and Taylor, K. (2011), DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabetic Medicine, 28: 705–714. doi: 10.1111/j.1464-5491.2011.03301.x
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- Issue published online: 16 MAY 2011
- Article first published online: 16 MAY 2011
- Accepted manuscript online: 22 MAR 2011 10:43AM EST
- Accepted 21 December 2010
- glucagon-like peptide 1;
- Type 2 diabetes
Diabet. Med. 28, 705–714 (2011)
Aims In the initial 26-week, double-blind, double-dummy assessment period of the DURATION-2 trial in patients with Type 2 diabetes on metformin, the once-weekly glucagon-like peptide 1 (GLP-1) receptor agonist exenatide once-weekly resulted in greater HbA1c improvement and weight reduction compared with maximum approved daily doses of sitagliptin or pioglitazone. This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Methods Randomised oral medications were discontinued and all patients received exenatide once-weekly. Of the 364 patients [original baseline HbA1c 8.5 ± 1.1% (70 mmol/mol), fasting plasma glucose 9.0 ± 2.5 mmol/l, weight 88 ± 20 kg) who continued into the open-label period, 319 patients (88%) completed 52 weeks.
Results Evaluable patients who received only exenatide once-weekly demonstrated significant 52-week improvements (least square mean ± se) in HbA1c (−1.6 ± 0.1%), fasting plasma glucose (−1.8 ± 0.3 mmol/l) and weight (−1.8 ± 0.5 kg). Evaluable patients who switched from sitagliptin to exenatide once-weekly demonstrated significant incremental improvements in HbA1c (−0.3 ± 0.1%), fasting plasma glucose (−0.7 ± 0.2 mmol/l) and weight (−1.1 ± 0.3 kg). Patients who switched from pioglitazone to exenatide once-weekly maintained HbA1c and fasting plasma glucose improvements (week 52: −1.6 ± 0.1%, −1.7 ± 0.3 mmol/l), with significant weight reduction (−3.0 ± 0.3 kg). Exenatide once-weekly was generally well tolerated and adverse events were predominantly mild or moderate in intensity. Nausea was the most frequent adverse event in this assessment period (intent-to-treat: exenatide once-weekly-only 5%; sitagliptin exenatide once-weekly 11%; pioglitazone exenatide once-weekly 10%). No major hypoglycaemia was observed.
Conclusions Patients who switched to once-weekly exenatide from daily sitagliptin or pioglitazone had improved or sustained glycaemic control, with weight loss.