Trial information
A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.
Status: Completed
Protocol number: NP19470
Sponsor: Hoffman-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study to investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics and safety of GK Activator (2) following a single oral dose administration in patients with type 2 diabetes.
Brief summary: This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 20.
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. Vital signs, adverse events, laboratory parameters. Time frame: Throughout study
Key secondary outcomes: 1. AUC, Tmax, Cmax, T1/2, CL/F, CLR for GK Activator (2) and metabolite. Glucose Cmax and Cmin, and percentage decrease in glucose from baseline. Time frame: Throughout study.
Inclusion criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for >=1 week prior to dosing with GK Activator (2);
- normal renal function, or moderate or severe impairment.
Exclusion criteria:
- type 1 diabetes;
- treatment with insulin or PPAR gamma agonist within 6 months of screening.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 08/16/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Slovakia
United States
- Cypress, CA
- San Antonio, TX
