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Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes

NCT01549964 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 916

Last updated 2016-06-02

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50 mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus metformin on lowering blood sugar.

Conditions

  • Glycemic Control

Interventions

DRUG

Fasiglifam (TAK-875)

Fasiglifam (TAK-875) tablets

DRUG

Sitagliptin

Sitagliptin tablets

DRUG

Placebo

Placebo-matching tablets

Sponsors & Collaborators

Principal Investigators

  • Senior Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Australia
  • Bulgaria
  • Croatia
  • Czechia
  • Hungary
  • Italy
  • Malaysia
  • Slovakia
  • South Korea
  • Thailand

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 NCT01549964 on ClinicalTrials.gov