Double-blind Comparative Study of SYR-472

This study is currently recruiting participants.

Verified January 2013 by Takeda Global Research & Development Center, Inc.

Sponsor:

Information provided by (Responsible Party):

Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )

ClinicalTrials.gov Identifier:

NCT01632007

First received: June 27, 2012

Last updated: January 17, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 27, 2012

Last Updated Date

January 17, 2013

Start Date ^ICMJE

May 2012

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks. ] [ Designated as safety issue: No ]

Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01632007 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Double-blind Comparative Study of SYR-472

Official Title ^ICMJE

Not Provided

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Drug: SYR-472
Drug: Alogliptin 25 mg
Other Name: SYR-322
Drug: Placebo

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

240

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

The participant is an outpatient.
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:

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)
The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact: Takeda Study Registration Call Center

+1-800-778-2860

medicalinformation@tpna.com

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01632007

Other Study ID Numbers ^ICMJE

SYR-472/CCT-002, U1111-1128-6104, JapicCTI-121839

Has Data Monitoring Committee

Responsible Party

Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )

Study Sponsor ^ICMJE

Takeda Pharmaceutical Company Limited

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Takeda Pharmaceutical Company Limited

Information Provided By

Takeda Global Research & Development Center, Inc.

Verification Date

January 2013

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

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