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Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes

NCT01834274 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2015-09-28

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of fasiglifam (TAK-875) plus metformin compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment Period.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Fasiglifam (TAK-875)

Fasiglifam (TAK-875) tablets

DRUG

Fasiglifam (TAK-875) Placebo

Fasiglifam (TAK-875) placebo-matching tablets

DRUG

Sitagliptin

Sitagliptin tablets

DRUG

Sitagliptin Placebo

Sitagliptin placebo-matching tablets

DRUG

Metformin

Metformin tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Argentina
  • Canada
  • Croatia
  • Hungary
  • Malaysia
  • Peru
  • Philippines
  • Poland
  • Russia
  • South Africa
  • Thailand
  • Ukraine

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 NCT01834274 on ClinicalTrials.gov