drugset / Trial / NCT00734474
A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin
Phase 2/3
Completed
1202 enrolled
Eli Lilly and Company
Berry Consultants · collabTessella Inc. · collabUnited BioSource, LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.
Timeline
- Start
- 2008-08
- Primary completion
- 2011-06
- Completion
- 2012-07
Outcome
Met primary endpoint
registry analysis (superiority or other test); 1.5 mg LY2189265 vs Sitagliptin; p <0.001; LS Mean Difference -0.71 (95% CI -0.87 to -0.55) NCT00734474 ↗
registry analysis (superiority or other test); 0.75 mg LY2189265 vs Sitagliptin; p <0.001; LS Mean Difference -0.47 (95% CI -0.63 to -0.31) NCT00734474 ↗
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.
- Sherman SI, Kloos RT, Tuttle RM, Pontecorvi A, Volzke H, Harper K, Vance C, Alston JT, Usborne AL, Sloop KW, Lakshmanan M. No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer. Diabet Med. 2018 Mar;35(3):381-385. doi: 10.1111/dme.13437.
- 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.
- Weinstock RS, Guerci B, Umpierrez G, Nauck MA, Skrivanek Z, Milicevic Z. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015 Sep;17(9):849-58. doi: 10.1111/dom.12479. Epub 2015 May 20.
- Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22.
- Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304. doi: 10.1177/193229681200600608.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dulaglutide | Peptide | 0.25 mg | Subcutaneous |
| Subject | Dulaglutide | Peptide | 0.5 mg | Subcutaneous |
| Subject | Dulaglutide | Peptide | 0.75 mg | Subcutaneous |
| Subject | Dulaglutide | Peptide | 1 mg | Subcutaneous |
| Subject | Dulaglutide | Peptide | 1.5 mg | Subcutaneous |
| Subject | Dulaglutide | Peptide | 2 mg | Subcutaneous |
| Subject | Dulaglutide | Peptide | 3 mg | Subcutaneous |
| Comparator | Sitagliptin | Small molecule | 100 mg | Oral |
| Background | Metformin | Small molecule | 1500 mg | Oral |