A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
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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.
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.
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.