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Long-term Study of SYR-472

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01431807
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: SYR-472 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SYR-472 group
(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
Drug: SYR-472
oral, for up to 52 weeks.


Outcome Measures

Primary Outcome Measures :
  1. Adverse events [ Time Frame: 52 weeks. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  3. Diabetes Mellitus

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 subinvestigator.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431807


Locations
Japan
Akita-shi, Akita, Japan
Kisarazu-shi, Chiba, Japan
Fukuoka-shi, Fukuoka, Japan
Munakata-shi, Fukuoka, Japan
Koriyama-shi, Fukushima, Japan
Gihu-shi, Gihu, Japan
Fukuyama-shi, Hiroshima, Japan
Hiroshima-shi, Hiroshima, Japan
Eniwa-shi, Hokkaido, Japan
Ishikari-shi, Hokkaido, Japan
Nakagawa-gun, Hokkaido, Japan
Obihiro-shi, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Kobe-shi, Hyogo, Japan
Mito-shi, Ibaragi, Japan
Naka-shi, Ibaragi, Japan
Takamatsu-shi, Kagawa, Japan
Sagamihara-shi, Kanagawa, Japan
Yokohama-shi, Kanagawa, Japan
Kumamoto-shi, Kumamoto, Japan
Tamana-shi, Kumamoto, Japan
Kyoto-shi, Kyoto, Japan
Nagano-shi, Nagano, Japan
Nagawaki-shi, Nagasaki, Japan
Oita-shi, Oita, Japan
Mino-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Sakai-shi, Osaka, Japan
Ageo-shi, Saitama, Japan
Kawaguchi-shi, Saitama, Japan
Koshigaya-shi, Saitama, Japan
Kuki-shi, Saitama, Japan
Saitama-shi, Saitama, Japan
Suntou-gun, Shizuoka, Japan
Oyama-shi, Tochigi, Japan
Chuo-ku, Tokyo, Japan
Koganei-shi, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Shibuya-ku, Tokyo, Japan
Tama-shi, Tokyo, Japan
Tiyoda-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Director Takeda
More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01431807     History of Changes
Other Study ID Numbers: SYR-472/OCT-001
JapicCTI-111592 ( Registry Identifier: JapicCTI )
U1111-1123-6415 ( Registry Identifier: WHO )
First Posted: September 12, 2011    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs