A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.

• Status: Terminated
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients with mild and moderate hepatic impairment. Patients with type 2 diabetes, and with normal hepatic function, or mild or moderate hepatic impairment, will receive a single dose of GK Activator (2) 100mg po before breakfast, for assessment of pharmacokinetic, pharmacodynamic and safety parameters. 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: Ethanol

Criteria

Inclusion Criteria:

• adult patients, 18-75 years of age;

• type 2 diabetes;

• normal hepatic function, or mild or moderate hepatic impairment.

Exclusion Criteria:

• type 1 diabetes, or latent autoimmune diabetes in adults;

• diabetic neuropathy, retinopathy or nephropathy;

• treatment with insulin or PPAR gamma agonist within 6 weeks of screening;

• clinically significant cardiovascular disease.