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

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: RO4998452

• Registration Number: NCT00933972
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 (normal)	RO4998452	-
2 (mild)	RO4998452	-
3 (moderate)	RO4998452	-
4 (severe)	RO4998452	-

Primary Outcome Measures

Name	Time	Method
Creatinine clearance; Pk parameters; adverse events	Days 1-3

Secondary Outcome Measures

Name	Time	Method
Blood glucose; meal tolerance test	Days 1-3