drugset / Trial / NCT02302716
A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs).
Timeline
- Start
- 2014-12
- Primary completion
- 2016-07
- Completion
- 2016-07
Outcome
Met primary endpoint
paper LY IGlar was noninferior to IGlar in terms of change in HbA1c level from baseline PMID 30604091 ↗
paper The upper limit of confidence interval (CI) for treatment difference was below the defined 0.4% noninferiority margin PMID 31119716 ↗
Publications
- Mohan V, Ahn KJ, Cho YM, Sahay RK, Huang CN, Kalra S, Chadha M, Bhattacharya I, Kim SY, Spaepen E. Lilly Insulin Glargine Versus Lantus(R) in Type 2 Diabetes Mellitus Patients: India and East Asia Subpopulation Analyses of the ELEMENT 5 Study. Clin Drug Investig. 2019 Aug;39(8):745-756. doi: 10.1007/s40261-019-00798-1.
- Pollom RK, Ilag LL, Lacaya LB, Morwick TM, Ortiz Carrasquillo R. Lilly Insulin Glargine Versus Lantus(R) in Insulin-Naive and Insulin-Treated Adults with Type 2 Diabetes: A Randomized, Controlled Trial (ELEMENT 5). Diabetes Ther. 2019 Feb;10(1):189-203. doi: 10.1007/s13300-018-0549-3. Epub 2019 Jan 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LY2963016 | Protein / enzyme biologic | 10 iu | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 10 iu | Subcutaneous |