Pancreatic safety in Japanese patients with type 2 diabetes treated with once weekly dulaglutide 0.75 mg up to 52 weeks in phase 3 clinical trials

Nov 18, 2016Endocrine journal

Pancreatic safety of once-weekly dulaglutide 0.75 mg for up to 52 weeks in Japanese adults with type 2 diabetes

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Abstract

In 3 phase 3 studies, 43 events suggestive of acute pancreatitis were adjudicated among 1,304 patients treated with dulaglutide, liraglutide, insulin glargine, or placebo.

  • Two patients treated with dulaglutide were confirmed to have acute pancreatitis, representing an incidence of 0.2%.
  • One event linked to dulaglutide was diagnosed without typical abdominal pain.
  • Transient increases in lipase levels were observed in 2% of patients in both dulaglutide and liraglutide groups.
  • The incidence of elevated lipase levels in dulaglutide-treated patients was similar to those treated with liraglutide, placebo, or insulin glargine.
  • Systematic assessments of pancreatic safety for up to 52 weeks indicate no increased risk of acute pancreatitis in Japanese patients treated with dulaglutide.

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