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
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Drug: Alogliptin
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 52 Weeks ]

Enrollment: 67
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYR-322 group
(long-term combination therapy with Rapid-Acting Insulin Secretagogues)
Drug: Alogliptin
oral, up to 52 weeks.
Other Name: SYR-322

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456130

Locations
Japan
Nagoya-shi, Aichi, Japan
Fukuoka-shi, Fukuoka, Japan
Kurume-shi, Fukuoka, Japan
Sapporo-shi, Hokkaido, Japan
Kobe-shi, Hyogo, Japan
Kagoshima-shi, Kagoshima, Japan
Kumamoto-shi, Kumamoto, Japan
Osaki-shi, Miyagi, Japan
Minou-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Kamio-shi, Saitama, Japan
Koshigaya-shi, Saitama, Japan
Adachi-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: General Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01456130     History of Changes
Other Study ID Numbers: SYR-322/OCT-901, U1111-1124-8848, JapicCTI-111643
Study First Received: October 13, 2011
Last Updated: June 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Alogliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014