- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431807
Long-term Study of SYR-472
December 7, 2023 updated by: Takeda
An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies
To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
680
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
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Akita
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Akita-shi, Akita, Japan
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Chiba
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Kisarazu-shi, Chiba, Japan
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan
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Munakata-shi, Fukuoka, Japan
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Fukushima
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Koriyama-shi, Fukushima, Japan
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Gihu
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Gihu-shi, Gihu, Japan
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Hiroshima
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Fukuyama-shi, Hiroshima, Japan
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Hiroshima-shi, Hiroshima, Japan
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Hokkaido
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Eniwa-shi, Hokkaido, Japan
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Ishikari-shi, Hokkaido, Japan
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Nakagawa-gun, Hokkaido, Japan
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Obihiro-shi, Hokkaido, Japan
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Sapporo-shi, Hokkaido, Japan
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Hyogo
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Kobe-shi, Hyogo, Japan
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Ibaragi
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Mito-shi, Ibaragi, Japan
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Naka-shi, Ibaragi, Japan
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Kagawa
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Takamatsu-shi, Kagawa, Japan
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Kanagawa
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Sagamihara-shi, Kanagawa, Japan
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Yokohama-shi, Kanagawa, Japan
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Kumamoto
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Kumamoto-shi, Kumamoto, Japan
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Tamana-shi, Kumamoto, Japan
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Kyoto
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Kyoto-shi, Kyoto, Japan
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Nagano
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Nagano-shi, Nagano, Japan
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Nagasaki
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Nagawaki-shi, Nagasaki, Japan
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Oita
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Oita-shi, Oita, Japan
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Osaka
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Mino-shi, Osaka, Japan
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Osaka-shi, Osaka, Japan
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Sakai-shi, Osaka, Japan
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Saitama
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Ageo-shi, Saitama, Japan
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Kawaguchi-shi, Saitama, Japan
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Koshigaya-shi, Saitama, Japan
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Kuki-shi, Saitama, Japan
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Saitama-shi, Saitama, Japan
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Shizuoka
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Suntou-gun, Shizuoka, Japan
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Tochigi
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Oyama-shi, Tochigi, Japan
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Tokyo
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Chuo-ku, Tokyo, Japan
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Koganei-shi, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Shibuya-ku, Tokyo, Japan
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Tama-shi, Tokyo, Japan
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Tiyoda-ku, Tokyo, Japan
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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:
- The participant is an outpatient.
- The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Diabetes Mellitus
Exclusion Criteria:
- The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- 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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SYR-472 group
(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
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oral, for up to 52 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Adverse events
Time Frame: 52 weeks.
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52 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Senior 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 (Actual)
September 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
September 8, 2011
First Submitted That Met QC Criteria
September 9, 2011
First Posted (Estimated)
September 12, 2011
Study Record Updates
Last Update Posted (Estimated)
December 14, 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/OCT-001
- JapicCTI-111592 (Registry Identifier: JapicCTI)
- U1111-1123-6415 (Registry Identifier: WHO)
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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