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A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)

NCT01863667 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2018-09-10

Study results available
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Summary

This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.

Conditions

Interventions

DRUG

Omarigliptin

Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly

DRUG

Glimepiride

Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal

DRUG

Omarigliptin Placebo

Matching placebo to omarigliptin capsule administered orally once weekly

DRUG

Glimepiride Placebo

Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-08
Primary Completion
2014-04-03
Completion
2014-04-03

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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 NCT01863667 on ClinicalTrials.gov