At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effect of MK-5160 in Subjects With Type 1 and Type 2 Diabetes Mellitus
In Brief
A Phase 1 clinical trial evaluating MK-5160 16 nmol/kg, MK-5160 32 nmol/kg, and 6 other interventions for Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. Completed, enrolled 33 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
MK-5160 16 nmol/kg, subcutaneous injection administered daily for 12 days
MK-5160 32 nmol/kg, subcutaneous injection administered daily for 12 days
MK-5160 64 nmol/kg, subcutaneous injection administered daily for 12 days
Glargine 0.4 U/kg, subcutaneous injection administered daily for 12 days
Placebo to glargine, subcutaneous injection administered daily for 12 days
Placebo to MK-5160, subcutaneous injection administered daily for 12 days
20% solution of dextrose; adjusted to maintain the various glycemic levels at 100 mg/dL given as a continuous intravenous infusion for 6-30 hours.
Glargine 0.6 U/kg, subcutaneous injection administered daily for 12 days