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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00933972

Enrollment

Registered

2009-07-08

Start date

2009-06-30

Completion date

2010-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Brief summary

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.

Interventions

DRUGRO4998452

20mg po single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Creatinine clearance; Pk parameters; adverse events	Days 1-3

Secondary

Measure	Time frame
Blood glucose; meal tolerance test	Days 1-3

Countries

Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026