Study of Combination Therapy With SYR-322

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01521962
First received: January 26, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: Alogliptin
Drug: Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) [ Time Frame: Baseline and Week 12 ]

Enrollment: 67
Study Start Date: February 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYR-322 (Alogliptin) QD
SYR-322 25 mg, orally.
Drug: Alogliptin
Alogliptin tablets
Other Name: SYR-322
Placebo Comparator: Insulin
injection
Drug: Insulin
Insulin injection

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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: NCT01521962

Locations
Japan
Aomori-shi, Aomori, Japan
Hirosaki-shi, Aomori, Japan
Kashiwa-shi, Chiba, Japan
Kisarazu-shi, Chiba, Japan
Kitakyushu-shi, Fukuoka, Japan
Aki-gun, Hiroshima, Japan
Fukuyama-shi, Hiroshima, Japan
Nishinomiya-shi, Hyogo, Japan
Koga-shi, Ibaraki, Japan
Ushiku-shi, Ibaraki, Japan
Kahoku-gun, Ishikawa, Japan
Hanamaki-shi, Iwate, Japan
Morioka-shi, Iwate, Japan
Kagoshima-shi, Kagoshima, Japan
Satsuma-sendai-shi, Kagoshima, Japan
Kumamoto-shi, Kumamoto, Japan
Minamata-shi, Kumamoto, Japan
Miyazaki-shi, Miyazaki, Japan
Nigata-shi, Nigata, Japan
Hirakata-shi, Osaka, Japan
Osaka-sayama-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Takatsuki-shi, Osaka, Japan
Yao-shi, Osaka, Japan
Kuki-shi, Saitama, Japan
Otsu-shi, Shiga, Japan
Hamamatsu-shi, Shizuoka, Japan
Shizuoka-shi, Shizuoka, Japan
Shimotsuke-shi, Tochigi, Japan
Shinagawa-ku, Tokyo, Japan
Toyama-shi, Toyama, Japan
Sagae-shi, Yamagata, Japan
Yamagata-shi, Yamagata, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01521962     History of Changes
Other Study ID Numbers: SYR-322/CCT-901, U1111-1127-1525, JapicCTI-121736
Study First Received: January 26, 2012
Last Updated: November 12, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Alogliptin
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014