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

Completed · Phase 1

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00933972

Run by

Hoffmann-La Roche

People needed

36

Starts

2009-06-01

Expected to finish

2010-09-01

Last updated by the study team

2016-11-02

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Study site — Renton, Washington, United States
• Study site — Moscow, Russia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.