Double-blind Comparative Study of SYR-472

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01632007
First received: June 27, 2012
Last updated: January 13, 2014
Last verified: January 2014

June 27, 2012
January 13, 2014
May 2012
July 2013   (final data collection date for primary outcome measure)
Glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks. ] [ Designated as safety issue: No ]
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
Not Provided

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: Double Blind (Subject, Caregiver, 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
Not Provided

*   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.
Both
20 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01632007
SYR-472/CCT-002, U1111-1128-6104, JapicCTI-121839
No
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