Diabetes Mellitus Type 2
Conditions
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.
Interventions
DRUGGK Activator (2)
100mg po
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs, adverse events, laboratory parameters. | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
Slovakia, United States
Outcome results
None listed