Study of Combination Therapy With SYR-322

This study is currently recruiting participants.

Verified January 2013 by Takeda

Sponsor:

Information provided by (Responsible Party):

Takeda ( Takeda Pharmaceutical Company Limited )

ClinicalTrials.gov Identifier:

NCT01521962

First received: January 26, 2012

Last updated: January 17, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 26, 2012

Last Updated Date

January 17, 2013

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) [ Time Frame: Baseline and Week 12 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01521962 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

Study of Combination Therapy With SYR-322

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Drug: Alogliptin
Alogliptin tablets

Other Name: SYR-322
Drug: Insulin
Insulin injection

Study Arm (s)

Experimental: SYR-322 (Alogliptin) QD
SYR-322 25 mg, orally.

Intervention: Drug: Alogliptin
Placebo Comparator: Insulin
injection

Intervention: Drug: Insulin

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

168

Completion Date

Not Provided

Estimated Primary Completion Date

November 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

Contacts ^ICMJE

Contact: Takeda Study Registration Call Center

800-778-2860

medicalinformation@tpna.com

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01521962

Other Study ID Numbers ^ICMJE

SYR-322/CCT-901, U1111-1127-1525, JapicCTI-121736

Has Data Monitoring Committee

Not Provided

Responsible Party

Takeda ( Takeda Pharmaceutical Company Limited )

Study Sponsor ^ICMJE

Takeda Pharmaceutical Company Limited

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Senior Manager

Takeda Pharmaceutical Company Limited

Information Provided By

Takeda

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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