A Study of RO4998452 in Type 2 Diabetes Patients With Varying Degrees of Renal Impairment
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Diabetes |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 8/3/2016 |
| Start Date: | June 2009 |
| End Date: | September 2010 |
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.
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.
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