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Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus

NCT00086502 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2016-02-05

Study results available
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Summary

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Comparator: Sitagliptin

Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24

DRUG

Comparator: Placebo

Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24

DRUG

Comparator: Pioglitazone

Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8

DRUG

Metformin

Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2005-11-30
Completion
2005-11-30

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Entities

Drugs
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 NCT00086502 on ClinicalTrials.gov