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MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

NCT00372060 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2017-05-12

Study results available
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Summary

The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.

Conditions

Interventions

DRUG

sitagliptin phosphate

Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks

DRUG

Comparator: sitagliptin phosphate (MK0431)

Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks

DRUG

Comparator: pioglitazone

pioglitazone once daily for 52 weeks

DRUG

Comparator: placebo (unspecified)

Placebo once daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-21
Primary Completion
2008-02-05
Completion
2008-02-05

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Entities

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 NCT00372060 on ClinicalTrials.gov