A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322

August 29, 2023 updated by: Takeda

A Phase 4, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study to Evaluate the Efficacy and Safety of AD-4833 When Orally Administered Once Daily as add-on to SYR-322 Versus SYR-322 Alone in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Treatment With SYR-322 in Addition to Diet and/or Exercise Therapy

To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 4

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
    • Aomori
      • Hirosaki-shi, Aomori, Japan
    • Chiba
      • Kisaratsu-shi, Chiba, Japan
    • Ehime
      • Matsuyama-shi, Ehime, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
      • Kitakyushu-shi, Fukuoka, Japan
      • Kurume-shi, Fukuoka, Japan
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan
      • Hiroshima-shi, Hiroshima, Japan
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan
    • Ibaraki
      • Koga-shi, Ibaraki, Japan
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japan
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan
    • Osaka
      • Suita-shi, Osaka, Japan
    • Saitama
      • Koshigaya-shi, Saitama, Japan
    • Shiga
      • Otsu-shi, Shiga, Japan
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan
      • Chuo-ku, Tokyo, Japan
      • Itabashi-ku, Tokyo, Japan
      • Meguro-ku, Tokyo, Japan
      • Minato-ku, Tokyo, Japan
      • Ohta-ku, Tokyo, Japan
      • Shinjuku-ku, Tokyo, Japan
    • Toyama
      • Toyama-shi, Toyama, Japan
    • Yamaguchi
      • Shimonoseki-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

No

Description

Inclusion Criteria:

  • Those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.
  • Those who can sign and date a written, informed consent form prior to the initiation of any study procedures.

Exclusion Criteria:

  • Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc.
  • Others who are assessed to be ineligible for the study 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
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SYR-322 25 mg , AD-4833 15 mg
Drug: AD-4833 15 mg
Experimental: SYR-322 25 mg , AD-4833 30 mg
Drug: AD-4833 30 mg
Placebo Comparator: SYR-322 25 mg , AD-4833 placebo
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated Hemoglobin (HbA1c)
Time Frame: 16 weeks
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)
16 weeks

Collaborators and Investigators

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

Sponsor

Takeda

Investigators

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

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

September 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 31, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (Estimated)

September 18, 2012

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYR-322-4833/CCT-901
  • U1111-1132-3209 (Registry Identifier: WHO)
  • JapicCTI-121916 (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.

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