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. Identifier: NCT01431807
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : June 14, 2016
Information provided by (Responsible Party):

September 8, 2011
September 12, 2011
June 14, 2016
September 2011
June 2013   (Final data collection date for primary outcome measure)
Adverse events [ Time Frame: 52 weeks. ]
Adverse events
Complete list of historical versions of study NCT01431807 on Archive Site
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Long-term Study of SYR-472
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.
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Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus
Drug: SYR-472
oral, for up to 52 weeks.
Experimental: SYR-472 group
(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
Intervention: Drug: SYR-472
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
JapicCTI-111592 ( Registry Identifier: JapicCTI )
U1111-1123-6415 ( Registry Identifier: WHO )
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Study Director: Senior Director Takeda
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP