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Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes

NCT01481116 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2454

Last updated 2016-06-01

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM).

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

TAK-875

TAK-875 25 mg, tablets, orally, once daily and metformin ≥1500 mg or Maximum Tolerated Dose (MTD) for up to 104 weeks.

DRUG

TAK-875

TAK-875 50 mg, tablets, orally, once daily and metformin ≥1500 mg or MTD for up to 104 weeks.

DRUG

Glimepiride

Glimepiride 1 mg, tablets, orally, once daily (up-titrated to 2 mg after 1 week of treatment. Up-titrated to a maximum of 6 mg in 2 mg increments/down titrated if recurrent (or severe) hypoglycemia occurs) and metformin ≥1500 mg or MTD for up to 104 weeks.

Sponsors & Collaborators

Principal Investigators

  • Senior 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
2012-01-31
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Canada
  • Colombia
  • Czechia
  • Estonia
  • Hong Kong
  • Israel
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • New Zealand
  • Philippines
  • Poland
  • Romania
  • Russia
  • South Africa
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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Entities

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 NCT01481116 on ClinicalTrials.gov