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Study to Evaluate the Safety and Efficacy of the Addition of Omarigliptin (MK-3102) Compared With the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026)

NCT01841697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 642

Last updated 2018-09-10

Study results available
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Summary

This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.

Conditions

Interventions

DRUG

Omarigliptin

Omarigliptin (MK-3102) 25 mg oral capsule once a week for 24 weeks

DRUG

Sitagliptin

Sitagliptin 100 mg oral tablet once a day for 24 weeks

DRUG

Placebo to omarigliptin

Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks

DRUG

Placebo to Sitagliptin

Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks

DRUG

Open-label Metformin

Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day

DRUG

Open-label Glimepiride

Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy

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
2013-06-13
Primary Completion
2014-11-17
Completion
2014-11-17

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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 NCT01841697 on ClinicalTrials.gov