Phase III trial with Trulicity (dulaglutide) shows superiority in type 2 diabetes- Eli Lilly

New data from a completed Phase III trial show Trulicity (dulaglutide) solution for injection 1.5 mg, from Eli Lilly, plus a sulfonylurea was significantly more effective than a sulfonylurea alone in lowering HbA1c from baseline after 24 weeks of treatment in type 2 diabetes patients. At the primary endpoint of 24 weeks, dulaglutide 1.5 mg plus sulfonylurea provided superior HbA1c reduction from baseline (-1.38%) compared to sulfonylurea with placebo (-0.11%).

Significantly more patients treated with dulaglutide 1.5 mg plus sulfonylurea (55.3%) achieved an HbA1c of less than 7% compared to sulfonylurea with placebo (18.9%) and dulaglutide plus a sulfonylurea significantly reduced fasting serum glucose levels (the amount of sugar in the blood in a fasting state) compared to sulfonylurea with placebo (-1.70 mmol/L vs. +0.16 mmol/L). As a secondary endpoint of the study, dulaglutide plus a sulfonylurea showed weight reduction from baseline (-0.91 kg), though the difference compared to sulfonylurea with placebo did not reach statistical significance. The most commonly reported adverse events were gastrointestinal-related and consistent with prior dulaglutide studies, including nausea (10.5%) and diarrhoea (8.4%). These data were presented at the 2015 International Diabetes Federation World Diabetes Congress.

Comment: In terms of competition, liraglutide (Victoza), from Novo Nordisk, has been gaining market share in the US while AstraZeneca's exenatide (Byetta, Bydureon) are also seeking patients. Dulaglutide is one of two newer drugs alongside albiglutide (Tanzeum) from GSK. Dulaglutide is the newest of the group, and is seen as a bigger threat than albiglutide, with analysts predicting that its once-weekly dosage will attract potential liraglutide patients and give it a leading share of the market.