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Aim  To compare the efficacy and safety of the once‐weekly oral dipeptidyl peptidase‐4 ( DPP ‐4) inhibitor omarigliptin or once‐daily  DPP ‐4 inhibitor sitagliptin in patients with type 2 diabetes ( T2DM ) and inadequate glycaemic control on metformin.    Materials and methods  Patients with  T2DM  with a glycated haemoglobin ( HbA1c ) concentration ≥6.5% to ≤9.0% while on a stable dose of metformin (≥1500 mg/d) were randomized in a double‐blind manner to receive omarigliptin 25 mg once weekly (n = 322) or sitagliptin 100 mg once daily (n = 320). The primary analysis assessed whether omarigliptin was non‐inferior to sitagliptin in reducing  HbA1c  at week 24, based on the criterion of having an upper bound of the 95% confidence interval ( CI ) about the difference less than the non‐inferiority bound of 0.3%.    Results  The mean baseline  HbA1c  was 7.5% in both groups. After 24 weeks, the least squares ( LS ) mean change in  HbA1c  from baseline was −0.47% in the omarigliptin group and −0.43% in the sitagliptin group, with a between‐group difference of −0.03% (95%  CI  −0.15, 0.08). This result met the prespecified criterion for declaring non‐inferiority. The  LS  mean change from baseline in fasting plasma glucose and the percentage of patients with  HbA1c  <7.0% or <6.5% at week 24 were similar in the two treatment groups. There were no notable differences in adverse events and the incidence of symptomatic hypoglycaemia was low and similar in the groups.    Conclusions  In patients with  T2DM  and inadequate glycaemic control on metformin, the addition of omarigliptin 25 mg once weekly or sitagliptin 100 mg once daily led to similar improvements in glycaemic control. Both agents were generally well tolerated with a low incidence of hypoglycaemia.

diabetes, obesity and metabolism

Randomized clinical trial comparing the efficacy and safety of treatment with the once‐weekly dipeptidyl peptidase‐4 ( DPP ‐4) inhibitor omarigliptin or the once‐daily  DPP ‐4 inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin monotherapy