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

Roche

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: RO4998452

Study type: Interventional

Funder types: Industry

Identifiers

NCT00933972

BP22321

2008-008128-34

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

1 (normal)

Experimental group

Treatment:

Drug: RO4998452

2 (mild)

Experimental group

Treatment:

Drug: RO4998452

3 (moderate)

Experimental group

Treatment:

Drug: RO4998452

4 (severe)

Experimental group

Treatment:

Drug: RO4998452