A Study of RO4998452 in Type 2 Diabetes Patients With Varying Degrees of Renal Impairment

Effect of Renal Impairment on Pharmacodynamics and Pharmacokinetics of RO4998452: A Multiple-center, Open-label, Parallel Group Study Following Single Oral Dosing of RO4998452 to Type 2 Diabetes Patients With Varying Degrees of Renal Impairment.

This 4 arm study will investigate the pharmacodynamics and pharmacokinetics of RO4998452 in type 2 diabetes patients with varying degrees of renal impairment. Eligible patients will be divided into 4 groups, with normal renal function, or mild, moderate or severe renal impairment. All patients will receive a single oral dose of RO4998452 in the fasted state.The anticipated time on study treatment is <3 months (single dose study)and the target sample size is <100 individuals.

Inclusion Criteria:

• adult patients, 40-80 years of age;
• type 2 diabetes;
• normal renal function, or impaired but stable renal function;
• stable with regard to medication or treatment regimen taken for renal impairment or diabetes.

Exclusion Criteria:

• patients with a renal transplant;
• end-stage renal disease, requiring dialysis;
• nephrotic syndrome, or a history of nephrectomy;
• type 1 diabetes mellitus.