Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Sulfonylurea in Subjects With Type 2 Diabetes in Japan
4 other identifiers
interventional
312
0 countries
N/A
Brief Summary
The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose.
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 Aug 2008
Shorter than P25 for phase_2 type-2-diabetes-mellitus
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
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 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
July 6, 2011
CompletedFebruary 3, 2012
February 1, 2012
8 months
March 16, 2011
June 8, 2011
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin (Week 12).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
Baseline and Week 12.
Secondary Outcomes (8)
Change From Baseline in Glycosylated Hemoglobin (Week 2).
Baseline and Week 2.
Change From Baseline in Glycosylated Hemoglobin (Week 4).
Baseline and Week 4.
Change From Baseline in Glycosylated Hemoglobin (Week 8).
Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 2).
Baseline and Week 2.
Change From Baseline in Fasting Plasma Glucose (Week 4).
Baseline and Week 4.
- +3 more secondary outcomes
Study Arms (3)
Alogliptin 12.5 mg QD and Glimepiride QD or BID
ACTIVE COMPARATORAlogliptin 25 mg QD and Glimepiride QD or BID
ACTIVE COMPARATORGlimepiride 1, 2, 3 or 4 mg QD or BID
ACTIVE COMPARATORInterventions
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Eligibility Criteria
You may qualify if:
- Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12).
- Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
- Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
- Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%\* of the value at 4 weeks after the initiation of the observation period (Week -8) (\*rounded off to the first decimal place).
- Was receiving specific diet and exercise (if any) therapies during the observation period.
You may not qualify if:
- \. Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0).
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)
Results Point of Contact
- Title
- General Manager
- Organization
- Japan Development Center, Pharmaceutical Development Division
Study Officials
- STUDY DIRECTOR
Professor, 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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- 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
August 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
February 3, 2012
Results First Posted
July 6, 2011
Record last verified: 2012-02