A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: GK Activator (2) (Drug); Glyburide (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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.
Clinical Details
Official title: 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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: AUC0-6h of plasma glucoseAUC0-12h of GK Activator (2) and metabolite. AUC0-tau of glyburide
Secondary outcome: AEs, laboratory parameters.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Locations and Contacts
CYPRESS, California 90630, United States
HONOLULU, Hawaii 96813, United States
BUFFALO, New York NY 14215, United States
SAN ANTONIO, Texas 78229, United States
Additional Information
Ending date: July 2007
Last updated: June 17, 2008
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