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MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

NCT00722371 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1615

Last updated 2017-05-12

Study results available
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Summary

A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.

Conditions

Interventions

DRUG

Sitagliptin phosphate

Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.

DRUG

Pioglitazone hydrochloride

Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.

DRUG

Matching placebo to sitagliptin

Matching placebo to sitagliptin orally once daily for 54 weeks.

DRUG

Matching placebo to pioglitazone

Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks.

DRUG

Metformin

Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-09-05
Primary Completion
2010-10-26
Completion
2011-03-25

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Entities

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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 NCT00722371 on ClinicalTrials.gov