drugset / Trial / NCT03095651

Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002)

NCT03095651

Phase 1 Completed 33 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, active- and placebo-controlled, double-blind trial of MK-5160 in participants with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM). This is a two-part trial, with three panels per part. T1DM (Part 1) and T2DM (Part 2) participants will be given daily fixed doses of MK-5160 in three predefined, increasing doses in each panel, or glargine (active comparator). The primary hypothesis of the trial is that at a dose with sufficient safety, the mean steady-state maximum level of glucose infusion rate (GIRmax) after MK-5160 administration in both T1DM and T2DM participants is between 1.5 and 4.5 mg/kg/min.

Timeline

Start
2017-04-12
Primary completion
2018-01-30
Completion
2018-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-5160 Unknown 16 unknown Subcutaneous
Subject MK-5160 Unknown 32 unknown Subcutaneous
Subject MK-5160 Unknown 64 unknown Subcutaneous
Comparator insulin glargine Protein / enzyme biologic 0.4 iu/kg Subcutaneous
Comparator insulin glargine Protein / enzyme biologic 0.6 iu/kg Subcutaneous
Background Dextrose Unknown Intravenous