The pancreatic safety of dulaglutide was assessed in an integrated analysis of 4 phase 2 and 5 phase 3 studies in 6005 patients with Type 2 Diabetes (T2D).1 

A blinded external adjudication committee evaluated and assessed the

• investigator-reported adverse events (AEs) of pancreatitis
• asymptomatic, confirmed increases in at least 1 pancreatic enzyme of ≥ 3 times the upper limit normal (ULN), and
• AEs of severe or serious abdominal pain without a known etiology.1

The incidence of acute pancreatitis was

• 0.07 % for dulaglutide compared to
• 0.14 % for placebo. 

Acute pancreatitis and pancreatitis have also been reported in the post-marketing setting.2

In the integrated analysis, a total of 203 events were adjudicated in 151 patients. Pancreatitis was confirmed in 9 patients, of which 

• 5 patients were treated with dulaglutide
• 3 patients were treated with sitagliptin, and
• 1 patient was receiving placebo.1

All 5 patients with confirmed pancreatitis who were being treated with dulaglutide had elevated pancreatic enzymes at baseline prior to initiation of dulaglutide.1

The REWIND study was an event-driven, randomized, double-blind, phase 3 study evaluating once-weekly dulaglutide 1.5 mg treatment compared with placebo when added to standard of care on a composite endpoint of major adverse cardiovascular events (death due to cardiovascular causes, nonfatal myocardial infarction or nonfatal stroke) (MACE-3) in adults with T2D and established cardiovascular disease and/or risk factors.3,4

The instance of pancreatitis, did not differ significantly between the dulaglutide and placebo treatment groups (Acute Pancreatitis in the Dulaglutide REWIND Study).4

The AWARD-11 trial was a phase 3, randomized, double-blind, active-controlled, parallel-arm study that assessed the efficacy and safety of dulaglutide 3.0 mg and 4.5 mg compared with dulaglutide 1.5 mg in patients with inadequately controlled T2D on concomitant metformin therapy.5

6 patients were reported with adjudication-confirmed acute pancreatitis including

• 1 patient, 0.2%, in the dulaglutide 1.5 mg group
• 2 patients, 0.3%, in the dulaglutide 3.0 mg group, and
• 3 patients, 0.5%, in the dulaglutide 4.5 mg  group.6

All cases were acute and were reported as mild in severity with no pancreatic complications.6

One patient who was assigned to dulaglutide 4.5 mg, with a confirmed case of acute pancreatitis, had a previously undisclosed history of pancreatitis and would have been excluded from enrollment had this been known at the time of screening.6