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

Hoffmann-La Roche36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Type 2

Interventions

RO4998452DRUG

20mg po single dose

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Renton, Washington, United States

Unnamed facility

Moscow, Russia

Outcomes

Primary Outcomes

Creatinine clearance; Pk parameters; adverse events

Time frame: Days 1-3

Secondary Outcomes

Blood glucose; meal tolerance test

Time frame: Days 1-3

Data from ClinicalTrials.gov

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