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

NCT03095651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-04-01

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

MK-5160 16 nmol/kg

MK-5160 16 nmol/kg, subcutaneous injection administered daily for 12 days

BIOLOGICAL

MK-5160 32 nmol/kg

MK-5160 32 nmol/kg, subcutaneous injection administered daily for 12 days

BIOLOGICAL

MK-5160 64 nmol/kg

MK-5160 64 nmol/kg, subcutaneous injection administered daily for 12 days

BIOLOGICAL

Glargine 0.4 U/kg

Glargine 0.4 U/kg, subcutaneous injection administered daily for 12 days

BIOLOGICAL

Placebo to Glargine

Placebo to glargine, subcutaneous injection administered daily for 12 days

BIOLOGICAL

Placebo to MK-5160

Placebo to MK-5160, subcutaneous injection administered daily for 12 days

DRUG

Dextrose

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.

BIOLOGICAL

Glargine 0.6 U/kg

Glargine 0.6 U/kg, subcutaneous injection administered daily for 12 days

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2018-01-30
Completion
2018-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095651 on ClinicalTrials.gov