A Study in Adults With Type 1 Diabetes

Phase 3 Completed 536 enrolled Eli Lilly and Company Boehringer Ingelheim · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.

Timeline

Start: 2011-08
Primary completion: 2012-08
Completion: 2013-04

Outcome

Missed primary endpoint

registry LY2963016 + Insulin Lispro vs Lantus + Insulin Lispro; p = 0.055; LS Mean Difference 0.108 (95% CI -0.002 to 0.219); ANCOVA NCT01421147 ↗

Publications

Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(R) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LY2963016	Protein / enzyme biologic	—	Subcutaneous
Comparator	insulin glargine	Protein / enzyme biologic	—	Subcutaneous
Background	Insulin Lispro	Protein / enzyme biologic	—	Subcutaneous