A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
Phase 1
Completed
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Drug: GK Activator (2)
- Registration Number
- NCT00388986
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 3 Glyburide - 1 GK Activator (2) - 2 GK Activator (2) - 1 Glyburide -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method AEs, laboratory parameters. Throughout study