Long-term Study of SYR-322

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01456130
First received: October 13, 2011
Last updated: June 3, 2013
Last verified: June 2013

October 13, 2011
June 3, 2013
October 2011
March 2013   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events [ Time Frame: 52 Weeks ]
Same as current
Complete list of historical versions of study NCT01456130 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Long-term Study of SYR-322
A Long-Term, Open-Label Study to Investigate the Long-Term Safety of SYR-322 When Used in Combination With Rapid-Acting Insulin Secretagogues in Subjects With Type 2 Diabetes in Japan

The purpose of this study is to evaluate the safety and efficacy of long-term treatment with SYR-322 in diabetic patients.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Diabetes Mellitus
Drug: Alogliptin
oral, up to 52 weeks.
Other Name: SYR-322
Experimental: SYR-322 group
(long-term combination therapy with Rapid-Acting Insulin Secretagogues)
Intervention: Drug: Alogliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. The subject is an outpatient.
  2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

  1. The subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
  2. The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.
Both
20 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01456130
SYR-322/OCT-901, U1111-1124-8848, JapicCTI-111643
Not Provided
Takeda
Takeda
Not Provided
Study Director: General Manager Takeda
Takeda
June 2013

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