A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)

Summary

The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.

Timeline

Start

2010-02

Primary completion

2012-05

Completion

2012-11

Outcome

Met primary endpoint

paper Statistical criteria for superiority were met with dulaglutide 1.5 mg and for noninferiority with dulaglutide 0.75 mg. PMID 26089386 ↗

release “statistically superior reduction in HbA1c from baseline compared to insulin glargine at 52 weeks in patients with type 2 diabetes on metformin and glimeperide (AWARD-2)” lilly.com ↗

Publications

• Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
• Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
• Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015 Dec;38(12):2241-9. doi: 10.2337/dc14-1625. Epub 2015 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dulaglutide	Peptide	0.75 mg	Subcutaneous
Subject	Dulaglutide	Peptide	1.5 mg	Subcutaneous
Comparator	insulin glargine	Protein / enzyme biologic	—	Subcutaneous
Background	Glimepiride	Small molecule	4 mg	Oral
Background	Metformin	Small molecule	1500 mg	Oral

Indications