Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR-322 When Used in Combination With Thiazolidine in Subjects With Type 2 Diabetes in Japan
2 other identifiers
interventional
336
0 countries
N/A
Brief Summary
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started May 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 18, 2011
CompletedResults Posted
Study results publicly available
September 2, 2011
CompletedFebruary 3, 2012
February 1, 2012
1.3 years
March 16, 2011
June 8, 2011
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events.
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
52 Weeks.
Secondary Outcomes (30)
Change From Baseline in Glycosylated Hemoglobin (Week 8).
Baseline and Week 8.
Change From Baseline in Glycosylated Hemoglobin (Week 12).
Baseline and Week 12.
Change From Baseline in Glycosylated Hemoglobin (Week 16).
Baseline and Week 16.
Change From Baseline in Glycosylated Hemoglobin (Week 20).
Baseline and Week 20.
Change From Baseline in Glycosylated Hemoglobin (Week 24).
Baseline and Week 24.
- +25 more secondary outcomes
Study Arms (2)
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
ACTIVE COMPARATORAlogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
ACTIVE COMPARATORInterventions
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Eligibility Criteria
You may qualify if:
- Had completed the core phase 2/3 thiazolidine add on study.
- The subject was capable of understanding and complying with protocol requirements.
- Signed a written, informed consent form prior to the initiation of any study procedure.
You may not qualify if:
- With clinical manifestation of hepatic impairment (e.g., an AST or ALT value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 thiazolidine add on study).
- With clinical manifestation of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of the core phase 2/3 thiazolidine add on study).
- With a history or symptoms of cardiac failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
331 participants were randomized in the core phase 2/3 thiazolidine (CCT-004) study and included in the Full Analysis Set in this study. 5 participants from CCT-004 study did not enter this study.
Results Point of Contact
- Title
- General Manager
- Organization
- Japan Development Center, Pharmaceutical Development Division
Study Officials
- STUDY DIRECTOR
Professor, Department of Medicine
Department of Medicine, Kawasaki Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2011
First Posted
March 18, 2011
Study Start
May 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
February 3, 2012
Results First Posted
September 2, 2011
Record last verified: 2012-02