A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
Summary
The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.
Timeline
- Start
- 2010-11
- Primary completion
- 2012-02
- Completion
- 2012-09
Outcome
Met primary endpoint
registry analysis (superiority or other test); 1.5 mg LY2189265 vs Insulin Glargine; p = 0.005; LS Mean Difference -0.22 (95% CI -0.38 to -0.07); ANCOVA NCT01191268 ↗
registry analysis (superiority or other test); 0.75 mg LY2189265 vs Insulin Glargine; p = 0.015; LS Mean Difference -0.17 (95% CI -0.33 to -0.02); ANCOVA NCT01191268 ↗
paper At 26 weeks, the adjusted mean change in HbA1c was greater in patients receiving dulaglutide 1·5 mg PMID 26009229 ↗
paper The adjusted mean difference versus glargine was -0·22% (95% CI -0·38 to -0·07, -2·40 mmol/mol [-4·15 to -0·77]; p=0·005) for dulaglutide 1·5 mg PMID 26009229 ↗
release “demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine in combination with insulin lispro at 26 weeks (AWARD-4)” lilly.com ↗
Publications
- Pantalone KM, Patel H, Yu M, Fernandez Lando L. Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Diabetes Obes Metab. 2018 Jun;20(6):1461-1469. doi: 10.1111/dom.13252. Epub 2018 Mar 23.
- 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.
- Blonde L, Jendle J, Gross J, Woo V, Jiang H, Fahrbach JL, Milicevic Z. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015 May 23;385(9982):2057-66. doi: 10.1016/S0140-6736(15)60936-9.
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 | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |