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.
Overview
- Phase
- Phase 1
- Intervention
- GK Activator (2)
- Conditions
- Diabetes Mellitus Type 2
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 5
- Primary Endpoint
- Vital signs, adverse events, laboratory parameters.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
1
Intervention: GK Activator (2)
2
Intervention: GK Activator (2)
3
Intervention: GK Activator (2)
Outcomes
Primary Outcomes
Vital signs, adverse events, laboratory parameters.
Time Frame: Throughout study
Secondary Outcomes
- 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.)