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Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)

NCT01704261 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2018-09-10

Study results available
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Summary

This study will examine the safety and efficacy of the addition of omarigliptin in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo.

Conditions

Interventions

DRUG

Omarigliptin

Omarigliptin 25 mg capsule administered orally once a week

DRUG

Matching placebo to Omarigliptin

Matching placebo to omarigliptin capsule administered orally once a week

DRUG

Glimepiride

Open-label glimepiride tablet(s) administered orally once daily for a total daily dose \>=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.

DRUG

Metformin

Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose \>=1500 mg

Sponsors & Collaborators

Principal Investigators

  • Medical Director, MD · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-18
Primary Completion
2014-12-23
Completion
2014-12-23

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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 NCT01704261 on ClinicalTrials.gov