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Aims  The  PDY6797  study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus ( T2DM ) insufficiently controlled with sulphonylureas with/without metformin.    Methods  This randomized, double‐blind, placebo‐controlled trial comprised a single‐dose assessment of lixisenatide 5 and 10 µg, and a 5‐ to 6‐week repeated dose‐escalation assessment of lixisenatide 5 to 30 µg once ( QD ) or twice daily ( BID ). The primary endpoint was change in postprandial plasma glucose ( PPG ) area under the curve ( AUC ) [0:29–4:30 h]  after a standardized breakfast at the highest tolerated lixisenatide dose. Change from baseline in glycated haemoglobin ( HbA1c ), 2‐h  PPG  and fasting plasma glucose ( FPG ) were assessed, as were adverse events.    Results  Change from baseline in  PPG AUC  [0:29–4:30 h]  with lixisenatide  QD  and  BID  was significantly greater than placebo (p < 0.0001 for all study populations), with particularly prominent effects in Japanese patients. Greater reductions in  PPG AUC  [0:29–4:30 h]  were seen with lixisenatide  QD  versus  BID , while the totality of evidence suggested that the lixisenatide 20 µg dose was optimal. In the overall population, changes from baseline for 2‐h  PPG ,  HbA1c  and  FPG  were significant with lixisenatide  QD  and  BID  versus placebo (p < 0.01 for all). Lixisenatide was well tolerated.    Conclusions  Lixisenatide significantly reduced  PPG AUC  [0:29–4:30 h]  versus placebo at the highest well‐tolerated dose in patients with  T2DM  treated with sulphonylureas with/without metformin and had a good safety and tolerability profile. Japanese patients experienced particular benefits with lixisenatide in terms of reductions in  PPG  excursions.

diabetes, obesity and metabolism

Pharmacodynamics of the glucagon‐like peptide‐1 receptor agonist lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus poorly controlled on sulphonylureas with/without metformin