CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 76 enrolled
Drug / intervention
MK-1293 +2 moredrug
Likely dose
MK-1293 0.4 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02059174
NCT02059174Phase 1Completed
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A Single Dose Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1293 and to Compare Its Pharmacologic Properties to Those of Another Basal Insulin in Subjects With Type I Diabetes

Merck Sharp & Dohme LLC·interventional·Posted Feb 11, 2014·Updated Sep 5, 2018

In Brief

A Phase 1 clinical trial evaluating MK-1293, EU-Lantus™, and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 76 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2014
Enrollment StartFeb 10, 2014
Primary CompletionMar 30, 2015
Study CompletionApr 27, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.4 years ago

Interventions

MK-1293drug

MK-1293 0.4 units/kg administered subcutaneously

EU-Lantus™drug

EU-Lantus™ 0.4 units/kg administered subcutaneously

Novolog™drug

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