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Study of Combination Therapy With SYR-322

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01521962
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Alogliptin Drug: Insulin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
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
Study Start Date : February 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SYR-322 (Alogliptin) QD
SYR-322 25 mg, orally.
Drug: Alogliptin
Alogliptin tablets
Other Name: SYR-322

Placebo Comparator: Insulin
Drug: Insulin
Insulin injection

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01521962

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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
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Study Director: Senior Manager Takeda

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Takeda Identifier: NCT01521962     History of Changes
Other Study ID Numbers: SYR-322/CCT-901
U1111-1127-1525 ( Registry Identifier: WHO )
JapicCTI-121736 ( Registry Identifier: JapicCTI )
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action