drugset / Trial / NCT01624259
A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.
Timeline
- Start
- 2012-06
- Primary completion
- 2013-11
- Completion
- 2013-11
Outcome
Met primary endpoint
paper INTERPRETATION: Once-weekly dulaglutide is non-inferior to once-daily liraglutide for least-squares mean reduction in HbA1c, with a similar safety and tolerability profile. PMID 25018121 ↗
registry analysis (non-inferiority or equivalence test); 1.5 mg LY2189265 vs 1.8 mg Liraglutide; p <0.001; LS Mean Difference -0.06 (95% CI -0.19 to 0.07); NCT01624259 ↗
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.
- Dungan KM, Povedano ST, Forst T, Gonzalez JG, Atisso C, Sealls W, Fahrbach JL. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014 Oct 11;384(9951):1349-57. doi: 10.1016/S0140-6736(14)60976-4. Epub 2014 Jul 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dulaglutide | Peptide | 1.5 mg | Subcutaneous |
| Comparator | Liraglutide | Peptide | 1.8 mg | Subcutaneous |
| Background | Metformin | Small molecule | 1500 mg | Oral |