MedTrace Logo

A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)

NCT01217073 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 685

Last updated 2018-09-10

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the hypothesis that treatment with study medication (omarigliptin; MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5 different doses of omarigliptin to identify which dose is the most effective in the treatment of type 2 diabetes.

Conditions

Interventions

DRUG

Omarigliptin

Omarigliptin 0.25, 1, 1.5, 10 or 25 mg oral capsule administered once weekly. For omarigliptin 3 mg, participants received two omarigliptin 1.5 mg capsules.

DRUG

Placebo to omarigliptin

Matching placebo to omarigliptin 0.25, 1, 1.5, 10 or 25 mg oral capsule administered once weekly. For matching placebo to omarigliptin 3 mg, participants received two matching placebo to omarigliptin 1.5 mg capsules.

DRUG

Pioglitazone

Pioglitazone 15 mg oral tablet or capsule administered once daily

DRUG

Metformin

Metformin 500 mg oral tablet administered once or twice daily

DRUG

Placebo to metformin

Matching placebo to metformin oral tablet administered once daily

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-10-08
Primary Completion
2012-01-03
Completion
2013-04-01

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01217073 on ClinicalTrials.gov