SYR-472 Open-label Study

December 7, 2023 updated by: Takeda
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 (Actual)

14

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
    • Osaka
      • Suita-shi, Osaka, 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:

-1. The participant is judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.

2. The participant can sign and date a written, informed consent form prior to the initiation of any study procedures.

Exclusion Criteria:

-1. The participant has concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease

. 2. The participant is 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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SYR-472 100mg
Drug: SYR-472

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose
Time Frame: 7 days
Blood Glucose
7 days

Collaborators and Investigators

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

Sponsor

Takeda

Investigators

  • Study Director: General Manager, 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 (Actual)

April 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimated)

December 18, 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

Other Study ID Numbers

  • SYR-472/OCT-002
  • U1111-1137-2768 (Registry Identifier: UTN (WHO))
  • JapicCTI-122024 (Registry Identifier: JapicCTI (Japan))

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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