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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
100mg po bid
10-20mg po daily
Unnamed facility
Cypress, California, United States
Unnamed facility
Honolulu, Hawaii, United States
Unnamed facility
Buffalo, New York, United States
Unnamed facility
San Antonio, Texas, United States
AUC0-6h of plasma glucose
Time frame: Days -1, 6 and 12
AUC0-12h of GK Activator (2) and metabolite.
Time frame: Days 6 and 12
AUC0-tau of glyburide
Time frame: Days -1 and 6
AEs, laboratory parameters.
Time frame: Throughout study
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