drugset / Trial / NCT01982630

Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003)

NCT01982630

Phase 1 Completed 87 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once daily compared to placebo and another diabetes drug in participants with Type 2 diabetes mellitus (T2DM). This study was modified by a protocol amendment to a 2-part trial to further test the safety and tolerability of MK-8521 at higher doses and to compare MK-8521 pharmacokinetics between participants with T2DM and healthy participants. An additional cohort of T2DM participants and a cohort of non-diabetic obese participants has been added.

Timeline

Start
2013-11-07
Primary completion
2014-10-03
Completion
2014-10-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Liraglutide Peptide 1.8 mg Subcutaneous
Subject MK-8521 Unknown 72 ug Subcutaneous
Subject MK-8521 Unknown 120 ug Subcutaneous
Subject MK-8521 Unknown 300 ug Subcutaneous

Indications