A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Glyburide

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.