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Aims  To evaluate 0.75 mg of dulaglutide, a once‐weekly glucagon‐like peptide‐1 receptor agonist, compared with once‐daily insulin glargine for glycaemic control in  J apanese patients with type 2 diabetes ( T2D ).    Methods  In this phase  III , randomized, open‐label, parallel‐group, 26‐week study, 361 patients with inadequately controlled  T2D  receiving sulphonylureas and/or biguanides, aged ≥20 years, with glycated haemoglobin ( HbA1c ) levels 7.0–10.0% (53–86 mmol/mol), inclusive, were randomized (1 : 1) to receive dulaglutide or glargine. Participants and investigators were not masked to treatment allocation. The primary measure was change from baseline in  HbA1c  at 26 weeks, analysed using a mixed‐effects model for repeated measures, with a predefined non‐inferiority margin of 0.4%.    Results  At week 26, least‐squares ( LS ) mean (standard error) reductions in  HbA1c  were −1.44 (0.05)% [−15.74 (0.55) mmol/mol] in the dulaglutide group and −0.90 (0.05)% [−9.84 (0.55) mmol/mol] in the glargine group. The mean between‐group treatment difference in  HbA1c  was −0.54% (95%  CI  −0.67, −0.41) [−5.90 mmol/mol (95%  CI  −7.32, −4.48)]; p < 0.001. Dulaglutide significantly reduced body weight compared with glargine at week 26 ( LS  mean difference −1.42 kg, 95%  CI  −1.89, −0.94; p < 0.001). The most frequent adverse events with dulaglutide treatment were nasopharyngitis and gastrointestinal symptoms. The incidence of hypoglycaemia was significantly lower with dulaglutide [47/181 (26%)] compared with glargine [86/180 (48%)], p < 0.001.    Conclusion  In  J apanese patients with  T2D  uncontrolled on sulphonylureas and/or biguanides, once‐weekly dulaglutide was superior to once‐daily glargine for reduction in  HbA1c  at 26 weeks. Although dulaglutide increased gastrointestinal symptoms, it was well tolerated, with an acceptable safety profile.

diabetes, obesity and metabolism

Efficacy and safety of once‐weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once‐daily insulin glargine in  J apanese patients with type 2 diabetes: a randomized, open‐label, phase  III , non‐inferiority study