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Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

NCT01289119 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2013-03-22

Study results available
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Summary

The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Alogliptin

Alogliptin tablets

DRUG

Placebo to alogliptin

Alogliptin placebo-matching tablets.

DRUG

Metformin

Stable metformin dose

DRUG

Pioglitazone

Stable pioglitazone dose

Sponsors & Collaborators

Principal Investigators

  • Professor Study Chair · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • China
  • Hong Kong
  • Taiwan

Study Locations

More Related Trials

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 NCT01289119 on ClinicalTrials.gov