Study of Combination Therapy With SYR-322

November 12, 2013 updated by: Takeda

A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan

To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aomori
      • Aomori-shi, Aomori, Japan
      • Hirosaki-shi, Aomori, Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan
      • Kisarazu-shi, Chiba, Japan
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan
    • Hiroshima
      • Aki-gun, Hiroshima, Japan
      • Fukuyama-shi, Hiroshima, Japan
    • Hyogo
      • Nishinomiya-shi, Hyogo, Japan
    • Ibaraki
      • Koga-shi, Ibaraki, Japan
      • Ushiku-shi, Ibaraki, Japan
    • Ishikawa
      • Kahoku-gun, Ishikawa, Japan
    • Iwate
      • Hanamaki-shi, Iwate, Japan
      • Morioka-shi, Iwate, Japan
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan
      • Satsuma-sendai-shi, Kagoshima, Japan
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
      • Minamata-shi, Kumamoto, Japan
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan
    • Nigata
      • Nigata-shi, Nigata, Japan
    • Osaka
      • Hirakata-shi, Osaka, Japan
      • Osaka-sayama-shi, Osaka, Japan
      • Osaka-shi, Osaka, Japan
      • Takatsuki-shi, Osaka, Japan
      • Yao-shi, Osaka, Japan
    • Saitama
      • Kuki-shi, Saitama, Japan
    • Shiga
      • Otsu-shi, Shiga, Japan
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan
      • Shizuoka-shi, Shizuoka, Japan
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan
    • Tokyo
      • Shinagawa-ku, Tokyo, Japan
    • Toyama
      • Toyama-shi, Toyama, Japan
    • Yamagata
      • Sagae-shi, Yamagata, Japan
      • Yamagata-shi, Yamagata, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SYR-322 (Alogliptin) QD
SYR-322 25 mg, orally.
Drug: Alogliptin
Alogliptin tablets
Other Names:
  • SYR-322
Placebo Comparator: Insulin
injection
Drug: Insulin
Insulin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value)
Time Frame: Baseline and Week 12
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 12, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYR-322/CCT-901
  • U1111-1127-1525 (Registry Identifier: WHO)
  • JapicCTI-121736 (Registry Identifier: JapicCTI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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