A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
An Open-label, Crossover Study to Investigate the Potential Pharmacodynamic and Potential Pharmacokinetic Interaction Between Glyburide and GK Activator(2) in Type 2 Diabetes Patients Inadequately Controlled With Glyburide as Standard Prescribed Therapy.
1 other identifier
interventional
18
1 country
4
Brief Summary
This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes-mellitus-type-2
Started Oct 2006
Typical duration for phase_1 diabetes-mellitus-type-2
4 active sites
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
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 16, 2006
CompletedFirst Posted
Study publicly available on registry
October 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedNovember 2, 2016
November 1, 2016
9 months
October 16, 2006
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
AUC0-6h of plasma glucose
Days -1, 6 and 12
AUC0-12h of GK Activator (2) and metabolite.
Days 6 and 12
AUC0-tau of glyburide
Days -1 and 6
Secondary Outcomes (1)
AEs, laboratory parameters.
Throughout study
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, aged 18-75 years;
- type 2 diabetes mellitus; currently on glyburide 10-20 mg/day for \>=3 months;
- untreated, or taken off anti-diabetic or statin therapy \>=2 weeks before study start.
You may not qualify if:
- type 1 diabetes mellitus, or latent autoimmune diabetes in adults;
- diabetic neuropathy, retinopathy or nephropathy;
- patients treated with insulin or PPAR gamma agonist with 6 weeks of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Cypress, California, 90630, United States
Unknown Facility
Honolulu, Hawaii, 96813, United States
Unknown Facility
Buffalo, New York, NY 14215, United States
Unknown Facility
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2006
First Posted
October 17, 2006
Study Start
October 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
November 2, 2016
Record last verified: 2016-11