Long-term Study of SYR-472

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01431807
First received: September 8, 2011
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.


Condition Intervention Phase
Diabetes Mellitus
Drug: SYR-472
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 52 weeks. ] [ Designated as safety issue: Yes ]

Enrollment: 680
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01431807     History of Changes
Other Study ID Numbers: SYR-472/OCT-001, JapicCTI-111592, U1111-1122-0130
Study First Received: September 8, 2011
Last Updated: November 5, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 22, 2014