A Study for Patients With Type 1 Diabetes

Summary

Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine

Timeline

Start

2010-01

Primary completion

2010-12

Completion

2011-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); LY2605541 vs Glargine; p <0.001; Least Squares Mean Difference (Final) -0.55 (90% CI -0.81 to -0.29) NCT01049412 ↗

paper LY2605541 met noninferiority and superiority criteria compared with insulin glargine in daily mean blood glucose PMID 23193209 ↗

Publications

• Background Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.
• Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21.
• Rosenstock J, Blevins TC, Bergenstal RM, Morrow LA, Qu Y, Jacober SJ. Reduction in short-acting insulin requirement accompanies improved glycemic control with basal insulin peglispro compared with insulin glargine in patients with type 1 diabetes. J Diabetes. 2016 Jan;8(1):166-9. doi: 10.1111/1753-0407.12332. Epub 2015 Nov 17. No abstract available.
• Rosenstock J, Bergenstal RM, Blevins TC, Morrow LA, Prince MJ, Qu Y, Sinha VP, Howey DC, Jacober SJ. Better glycemic control and weight loss with the novel long-acting basal insulin LY2605541 compared with insulin glargine in type 1 diabetes: a randomized, crossover study. Diabetes Care. 2013 Mar;36(3):522-8. doi: 10.2337/dc12-0067. Epub 2012 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin Peglispro	Protein / enzyme biologic	—	Subcutaneous
Subject	insulin glargine	Protein / enzyme biologic	—	Subcutaneous

Indications