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)

NCT02059174

Phase 1 Completed 76 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
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