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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
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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