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CompletedNCT01433393Updated Nov 9, 2012

Double-blind Comparative Study of TAK-875

A Phase 3 interventional study of TAK-875 and TAK-875 in Diabetes Mellitus, sponsored by Takeda. Completed at 19 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-11-09.

Sponsored by Takeda · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
192
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Drug Therapy
03

In context

Diabetes Mellitus

11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 192 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Takeda is the lead sponsor of 1,025 studies on the registry; 91 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The participant is an outpatient.
  2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion criteria

Exclusion Criteria:

  1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
  2. The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.
05

Study design

Phase
Phase 3
Intervention model
Parallel assignment
Enrollment
192 participants (actual)

Study arms

  • Experimental
    TAK-875 25 mg

    Drug: TAK-875

  • Experimental
    TAK-875 50 mg

    Drug: TAK-875

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. HbA1c

07

Study locations

19 sites
  • Kisarazu-shi, Chiba, Japan
  • Matsuyama, Ehime, Japan
  • Fukuoka-shi Nishi-ku, Fukuoka, Japan
  • Kasuga-shi, Fukuoka, Japan
  • Naka, Ibaragi, Japan
  • Tsuchiura-shi, Ibaragi, Japan
  • Takamatsu, Kagawa-ken, Japan
  • Kyoto-shi Fushimi-ku, Kyoto, Japan
  • Nagasaki, Nagasaki, Japan
  • Kashihara-shi, Nara, Japan
  • Kashiwara-shi, Osaka, Japan
  • Osaka-shi Tsurumi-ku, Osaka, Japan
  • Sakai-shi Nishi-ku, Osaka, Japan
  • Shimotsuke-shi, Tochigi, Japan
  • Chiyoda-ku, Tokyo, Japan
  • Itabashi-ku, Tokyo, Japan
  • Ōta-ku, Tokyo, Japan
  • Shinjuku-ku, Tokyo, Japan
  • Toshima-ku, Tokyo, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01433393
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Sep 14, 2011
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Nov 9, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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