A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.
Phase 1
Terminated
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: GK Activator (2)
- Registration Number
- NCT00437606
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 GK Activator (2) - 3 GK Activator (2) - 3 Ethanol - 2 Ethanol -
- Primary Outcome Measures
Name Time Method AUCo-inf and Cmax of plasma and urine GK Activator (2) and M4. AUC0-6 of plasma glucose. Days 1, 8 and 15
- Secondary Outcome Measures
Name Time Method tmax, AUC0-6, AUC0-last, t1/2, CL/F, Ac, CL for GK Activator (2) and M4. Cmin, Cmax, tmax and tmin of plasma glucose. Days 1, 8 and 15 AEs, laboratory parameters. Throughout study