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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1293 Compared With a Basal Insulin in Participants With Type 1 Diabetes (MK-1293-005)

NCT02059174 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2018-09-05

Study results available
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Summary

The purpose of this study is to assess the safety, pharmacokinetics, and pharmacodynamics of MK-1293 compared with a basal insulin (EU-Lantus™) in participants with Type 1 Diabetes. The primary hypotheses are that the duration of action, pharmacodynamic profile, and pharmacokinetic profile of MK-1293 and the comparator basal insulin are similar.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

MK-1293

MK-1293 0.4 units/kg administered subcutaneously

DRUG

EU-Lantus™

EU-Lantus™ 0.4 units/kg administered subcutaneously

DRUG

Novolog™

Participants will receive an intravenous infusion of insulin aspart (Novolog™ or other rapid-acting insulin analog) for several hours prior to MK-1293 or EU-Lantus™ dosing in each dosing period to meet basal insulin requirements

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-02-10
Primary Completion
2015-03-30
Completion
2015-04-27

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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 NCT02059174 on ClinicalTrials.gov