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Double-blind Comparative Study of SYR-472

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632007
First Posted: June 29, 2012
Last Update Posted: January 14, 2014
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.
Information provided by (Responsible Party):
Takeda
June 27, 2012
June 29, 2012
January 14, 2014
May 2012
July 2013   (Final data collection date for primary outcome measure)
Glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks. ]
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).
Same as current
Complete list of historical versions of study NCT01632007 on ClinicalTrials.gov Archive Site
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Double-blind Comparative Study of SYR-472
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The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.
Not Provided
Interventional
Phase 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: SYR-472
  • Drug: Alogliptin 25 mg
    Other Name: SYR-322
  • Drug: Placebo
  • Experimental: SYR-472 100 mg
    Intervention: Drug: SYR-472
  • Active Comparator: Alogliptin 25 mg
    Intervention: Drug: Alogliptin 25 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Inagaki N, Onouchi H, Maezawa H, Kuroda S, Kaku K. Once-weekly trelagliptin versus daily alogliptin in Japanese patients with type 2 diabetes: a randomised, double-blind, phase 3, non-inferiority study. Lancet Diabetes Endocrinol. 2015 Mar;3(3):191-7. doi: 10.1016/S2213-8587(14)70251-7. Epub 2015 Jan 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
July 2013
July 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01632007
SYR-472/CCT-002
U1111-1128-6104 ( Registry Identifier: WHO )
JapicCTI-121839 ( Registry Identifier: JapicCTI )
No
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Takeda
Takeda
Not Provided
Study Director: Medical Director Takeda
Takeda
January 2014

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