drugset / Trial / NCT02059174
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1293 Compared With a Basal Insulin in Participants With Type 1 Diabetes (MK-1293-005)
RandomizedCrossoverTriple-blindTreatment
Summary
The purpose of this study is to assess the safety, pharmacokinetics, and pharmacodynamics of MK-1293 compared with a basal insulin (EU-Lantus™) in participants with Type 1 Diabetes. The primary hypotheses are that the duration of action, pharmacodynamic profile, and pharmacokinetic profile of MK-1293 and the comparator basal insulin are similar.
Timeline
- Start
- 2014-02-10
- Primary completion
- 2015-03-30
- Completion
- 2015-04-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EU-Lantus® | Unknown | 0.4 iu/kg | Subcutaneous |
| Subject | MK-1293 | Protein / enzyme biologic | 0.4 iu/kg | Subcutaneous |
| Background | insulin aspart | Protein / enzyme biologic | — | Intravenous |