Long-term Study of SYR-322

This study is currently recruiting participants.

Verified May 2012 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:

NCT01456130

First received: October 13, 2011

Last updated: May 17, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 13, 2011

Last Updated Date

May 17, 2012

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants with Adverse Events [ Time Frame: 52 Weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01456130 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

Long-term Study of SYR-322

Official Title ^ICMJE

A Long-Term, Open-Label Study to Investigate the Long-Term Safety of SYR-322 When Used in Combination With Rapid-Acting Insulin Secretagogues in Subjects With Type 2 Diabetes in Japan

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of long-term treatment with SYR-322 in diabetic patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Intervention Model: Single Group Assignment

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Drug: Alogliptin

oral, up to 52 weeks.

Other Name: SYR-322

Study Arm (s)

Experimental: SYR-322 group

(long-term combination therapy with Rapid-Acting Insulin Secretagogues)

Intervention: Drug: Alogliptin

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

Completion Date

Not Provided

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

The subject is an outpatient.
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:

The subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
The subject 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

800-778-2860

medicalinformation@tpna.com

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01456130

Other Study ID Numbers ^ICMJE

SYR-322/OCT-901, U1111-1124-8848, JapicCTI-111643

Has Data Monitoring Committee

Not Provided

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:

General Manager

Takeda Pharmaceutical Company Limited

Information Provided By

Takeda Global Research & Development Center, Inc.

Verification Date

May 2012

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

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