Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan
A Long-term, Open-label Extension Study to Investigate the Long-term Safety of Alogliptin When Used in Combination With Sulfonylurea or Metformin in Subjects With Type 2 Diabetes in Japan
3 other identifiers
interventional
576
0 countries
N/A
Brief Summary
To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).
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 Jan 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
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
August 16, 2012
CompletedAugust 16, 2012
July 1, 2012
1 year
March 16, 2011
June 8, 2011
July 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events.
Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment 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 (4)
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
ACTIVE COMPARATORAlogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
ACTIVE COMPARATORAlogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
ACTIVE COMPARATORAlogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
ACTIVE COMPARATORInterventions
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Eligibility Criteria
You may qualify if:
- Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
- Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
- 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:
- Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
- With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
- With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
- With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).
- Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:
- \. With history or symptoms of lactic acidosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Related Publications (1)
Seino Y, Hiroi S, Hirayama M, Kaku K. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Investig. 2012 Dec 20;3(6):517-25. doi: 10.1111/j.2040-1124.2012.00226.x. Epub 2012 Jul 12.
PMID: 24843617DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- General Manager
- Organization
- Japan Development Center, Pharmaceutical Development Division
Study Officials
- STUDY DIRECTOR
Professor, Diabetes and Endocrine Division
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
January 1, 2009
Primary Completion
January 1, 2010
Study Completion
April 1, 2010
Last Updated
August 16, 2012
Results First Posted
August 16, 2012
Record last verified: 2012-07