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Efficacy of Alogliptin and Pioglitazone in Subjects With Type 2 Diabetes Mellitus

NCT00432276 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 803

Last updated 2013-04-04

Study results available
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Summary

The purpose of the study is to compare the effect of adding alogliptin, once daily (QD), to the ongoing treatment regimen of pioglitazone HCl and metformin in patients with inadequate glycemic control.

Conditions

Interventions

DRUG

Alogliptin

Alogliptin tablets.

DRUG

Pioglitazone

Pioglitazone tablets.

DRUG

Metformin

Metformin HCl tablets (immediate-release, commercially available formulation) ≥1500 mg or maximum tolerated dose.

DRUG

Placebo

Matching placebo tablets.

Sponsors & Collaborators

Principal Investigators

  • VP Biological Sciences · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-05-31
Completion
2009-06-30

Countries

  • United States

Study Locations

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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 NCT00432276 on ClinicalTrials.gov