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An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

NCT00094757 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 521

Last updated 2019-05-30

Study results available
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Summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Comparator: sitagliptin 100 mg

sitagliptin 100 mg oral tablet once daily for 54 weeks

DRUG

Comparator: sitagliptin 200 mg

sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks

DRUG

Comparator: placebo

placebo oral tablet once daily during Phase A (Weeks 0-18)

DRUG

Comparator: pioglitazone

pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-10-06
Primary Completion
2005-08-17
Completion
2006-04-28

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Entities

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 NCT00094757 on ClinicalTrials.gov