Double-blind Comparative Study of SYR-472

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01632007
First received: June 27, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.


Condition Intervention Phase
Diabetes Mellitus
Drug: SYR-472
Drug: Alogliptin 25 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks. ] [ Designated as safety issue: No ]
    Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).


Estimated Enrollment: 245
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYR-472 100 mg Drug: SYR-472
Active Comparator: Alogliptin 25 mg Drug: Alogliptin 25 mg
Other Name: SYR-322
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

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

Exclusion Criteria:

  1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.(e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period)
  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: NCT01632007

Locations
Japan
Akita-shi, Akita, Japan
Matsudo-shi, Chiba, Japan
Fukuoka-shi, Fukuoka, Japan
Fukuyama-shi, Hiroshima, Japan
Ishikari-shi, Hokkaido, Japan
Nakagawa-gun, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Naka-shi, Ibaragi, Japan
Sagamihara-shi, Kanagawa, Japan
Kumamoto-shi, Kumamoto, Japan
Kashiwara-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Arakawa-ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Katsushika-ku, Tokyo, Japan
Mitaka-shi, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shunan-shi, Yamaguchi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01632007     History of Changes
Other Study ID Numbers: SYR-472/CCT-002, U1111-1128-6104, JapicCTI-121839
Study First Received: June 27, 2012
Last Updated: January 13, 2014
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 July 28, 2014