drugset / Trial / NCT03286751
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
RandomizedCrossoverDouble-blindBasic science
Summary
This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs are given by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 7 to 12 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
Timeline
- Start
- 2017-10-13
- Primary completion
- 2018-02-06
- Completion
- 2018-02-06
Publications
- Leohr J, Dellva MA, Carter K, LaBell E, Linnebjerg H. Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog(R) Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data. Clin Pharmacokinet. 2021 Nov;60(11):1423-1434. doi: 10.1007/s40262-021-01030-0. Epub 2021 May 27.
- Leohr J, Dellva MA, LaBell E, Coutant DE, Klein O, Plum-Moerschel L, Zijlstra E, Linnebjerg H. Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro vs Lispro Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects. Clin Ther. 2020 Sep;42(9):1762-1777.e4. doi: 10.1016/j.clinthera.2020.07.005. Epub 2020 Sep 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin Lispro | Protein / enzyme biologic | 7 unknown | — |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 7 unknown | Subcutaneous |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 15 unknown | — |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 15 unknown | Subcutaneous |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 30 unknown | — |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 30 unknown | Subcutaneous |