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Efficacy and Safety of TAK-875 in Subjects With Type 2 Diabetes Mellitus

NCT01007097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2016-04-13

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of multiple doses of TAK-875, once daily (QD), in subjects with Type 2 Diabetes Mellitus.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

TAK-875

TAK-875 6.25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.

DRUG

TAK-875

TAK-875 25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.

DRUG

TAK-875

TAK-875 50 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.

DRUG

TAK-875

TAK-875 100 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks

DRUG

TAK-875

TAK-875 200 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks

DRUG

Glimepiride

TAK-875 placebo-matching tablets and Glimepiride 2 mg or 4mg, capsules, orally, once daily for up to 12 weeks.

DRUG

Placebo

TAK-875 placebo-matching tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · 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
2009-12-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States
  • Guatemala
  • Mexico

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 NCT01007097 on ClinicalTrials.gov