drugset / Trial / NCT03170544

Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001)

NCT03170544

Phase 1 Completed 69 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This is an active- and placebo-controlled, single-site, four-part trial of MK-1092 in healthy adult participants, in participants with type 1 diabetes mellitus (T1DM), and in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis for this study is that at a dose with sufficient safety, the mean maximal glucose infusion rate (GIRmax) after single subcutaneous (SC) administration of MK-1092 in adult participants with T1DM is within an acceptable range. (Part 3)

Timeline

Start
2017-08-16
Primary completion
2018-11-08
Completion
2018-11-08

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-1092 Protein / enzyme biologic 4 unknown Subcutaneous
Subject MK-1092 Protein / enzyme biologic 8 unknown Subcutaneous
Subject MK-1092 Protein / enzyme biologic 16 unknown Subcutaneous
Subject MK-1092 Protein / enzyme biologic 32 unknown Subcutaneous
Subject MK-1092 Protein / enzyme biologic 64 unknown Subcutaneous
Comparator insulin glargine Protein / enzyme biologic 3 unknown Subcutaneous
Background Insulin Protein / enzyme biologic Intravenous
Background Insulin Lispro Protein / enzyme biologic 1.2 unknown Intravenous