Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.

NCT00328627 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1554

Last updated 2013-04-04

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.

Conditions

Interventions

DRUG

Alogliptin

Alogliptin tablets.

DRUG

Alogliptin placebo

Alogliptin placebo-matching tablets.

DRUG

Pioglitazone

Pioglitazone tablets.

DRUG

Pioglitazone placebo

Pioglitazone placebo-matching tablets.

Sponsors & Collaborators

Principal Investigators

  • VP Biological Sciences · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Australia
  • Brazil
  • Bulgaria
  • Chile
  • Croatia
  • Estonia
  • Guatemala
  • India
  • Israel
  • Latvia
  • Mexico
  • New Zealand
  • Peru
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Ukraine

Study Locations

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Entities

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 NCT00328627 on ClinicalTrials.gov