DURATION‐2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once‐weekly exenatide

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Abstract
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.

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