A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.
Phase 1
Completed
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Drug: GK Activator (2)
- Registration Number
- NCT00368368
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 GK Activator (2) - 3 GK Activator (2) - 1 GK Activator (2) -
- Primary Outcome Measures
Name Time Method Vital signs, adverse events, laboratory parameters. Throughout study
- Secondary Outcome Measures
Name Time Method 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. Throughout study.