Trial information
A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.
Status: Terminated
Protocol number: NP20131
Sponsor: F. Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A nonrandomized, open label study to examine the effect of hepatic impairment on the pharmacokinetics/pharmacodynamics and safety/tolerability of GK Activator (2) in patients with type 2 diabetes.'
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. Target sample size is 24.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Pharmacokinetics/dynamics study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: GK Activator (2)
Primary outcome: 1. AUCo-inf and Cmax of plasma and urine GK Activator (2) and M4. AUC0-6 of plasma glucose. Time frame: Days 1, 8 and 15
Key secondary outcomes: 1. 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. Time frame: Days 1, 8 and 15
2. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 02/16/2007
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Germany
Slovakia
