Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)

Phase 3 Completed 300 enrolled Eli Lilly and Company

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide compared to placebo in participants with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy.

Timeline

Start: 2013-01
Primary completion: 2014-12
Completion: 2014-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Dulaglutide vs Placebo; p <0.001; LS Squares Mean Difference -1.27 (95% CI -1.57 to -0.97); Mixed Models Analysis NCT01769378 ↗

release “At the primary endpoint of 24 weeks, Trulicity 1.5 mg plus sulfonylurea provided superior A1C reduction from baseline” lilly.com ↗

Publications

Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dulaglutide	Peptide	1.5 mg	Subcutaneous
Background	Glimepiride	Small molecule	—	Oral