Double-blind Comparative Study of SYR-472

December 7, 2023 updated by: Takeda
The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

245

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Akita
      • Akita-shi, Akita, Japan
    • Chiba
      • Matsudo-shi, Chiba, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan
    • Hokkaido
      • Ishikari-shi, Hokkaido, Japan
      • Nakagawa-gun, Hokkaido, Japan
      • Sapporo-shi, Hokkaido, Japan
    • Ibaragi
      • Naka-shi, Ibaragi, Japan
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
    • Osaka
      • Kashiwara-shi, Osaka, Japan
      • Osaka-shi, Osaka, Japan
      • Suita-shi, Osaka, Japan
    • Tokyo
      • Arakawa-ku, Tokyo, Japan
      • Bunkyo-ku, Tokyo, Japan
      • Chiyoda-ku, Tokyo, Japan
      • Chuo-ku, Tokyo, Japan
      • Itabashi-ku, Tokyo, Japan
      • Katsushika-ku, Tokyo, Japan
      • Mitaka-shi, Tokyo, Japan
      • Shinjuku-ku, Tokyo, Japan
    • Yamaguchi
      • Shunan-shi, Yamaguchi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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:

  1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.（e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period)
  2. The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: SYR-472 100 mg
Drug: SYR-472
Active Comparator: Alogliptin 25 mg
Drug: Alogliptin 25 mg
Other Names:
  • SYR-322

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated hemoglobin (HbA1c)
Time Frame: 24 weeks.
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).
24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Medical Director, Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 27, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (Estimated)

June 29, 2012

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYR-472/CCT-002
  • U1111-1128-6104 (Registry Identifier: WHO)
  • JapicCTI-121839 (Registry Identifier: JapicCTI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe