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):

January 26, 2012
January 31, 2012
November 13, 2013
February 2012
March 2013   (Final data collection date for primary outcome measure)
Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) [ Time Frame: Baseline and Week 12 ]
Same as current
Complete list of historical versions of study NCT01521962 on Archive Site
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Study of Combination Therapy With SYR-322
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Diabetes Mellitus
  • Drug: Alogliptin
    Alogliptin tablets
    Other Name: SYR-322
  • Drug: Insulin
    Insulin injection
  • Experimental: SYR-322 (Alogliptin) QD
    SYR-322 25 mg, orally.
    Intervention: Drug: Alogliptin
  • Placebo Comparator: Insulin
    Intervention: Drug: Insulin
Kaku K, Mori M, Kanoo T, Katou M, Seino Y. Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase. Expert Opin Pharmacother. 2014 Oct;15(15):2121-30. doi: 10.1517/14656566.2014.956722. Epub 2014 Sep 5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
U1111-1127-1525 ( Registry Identifier: WHO )
JapicCTI-121736 ( Registry Identifier: JapicCTI )
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Study Director: Senior Manager Takeda
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP