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.”

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

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics/Dynamics Study

Intervention(s) in this Clinical Trial

• Drug: GK Activator (2)
  • 100mg po bid
• Drug: Glyburide
  • 10-20mg po daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3

Primary Measures

• AUC0-6h of plasma glucose
  • Time Frame: Days -1, 6 and 12
    Safety Issue?: No
• AUC0-12h of GK Activator (2) and metabolite.
  • Time Frame: Days 6 and 12
    Safety Issue?: No
• AUC0-tau of glyburide
  • Time Frame: Days -1 and 6
    Safety Issue?: No

Secondary Measures

• AEs, laboratory parameters.
  • Time Frame: Throughout study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00388986

Study ID Number: NP20194

ClinicalTrials.gov Identifier: NCT00388986

Health Authority: United States: Food and Drug Administration