Official Title: “A Randomized, Open-Label Crossover Study to Investigate the Potential Interaction Between GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes”

This study will assess the potential pharmacokinetic interaction between GK Activator (2) and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6 treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin 80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: GK Activator (2)
  • 100mg po
• Drug: Simvastatin
  • 80mg po

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• AUC0-inf of GK Activator (2) and simvastatin acid.
  • Time Frame: Days 1, 8 and 15
    Safety Issue?: No
• AUC0-6h of plasma glucose from pre-dose to 6h post-dose.
  • Time Frame: Days 1, 8 and 15
    Safety Issue?: No

Secondary Measures

• AUC0-6h of GK Activator (2) and simvastatin acid
  • Time Frame: Days 1, 8 and 15
    Safety Issue?: No
• AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2.
  • Time Frame: Days 1, 8 and 15
    Safety Issue?: No
• Cmin, tmin, Cmax, tmax, plasma glucose.
  • Time Frame: Days 1, 8 and 15
    Safety Issue?: No
• AEs, laboratory parameters.
  • Time Frame: Throughout study
    Safety Issue?: No

Inclusion Criteria:

• adult patients aged 18-75 years;
• type 2 diabetes mellitus;
• 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 within 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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00377442

Study ID Number: NP20413

ClinicalTrials.gov Identifier: NCT00377442

Health Authority: United States: Food and Drug Administration