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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00933972
• Collaborator: (none)
• Enrollment: 36
• Locations: 2
• Arms: 4
• Duration (Months): 15
• Patients Per Site: 18
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2	Drug: RO4998452	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 (normal)	Drug: RO4998452; 20mg po single dose
Experimental: 2 (mild)	Drug: RO4998452; 20mg po single dose
Experimental: 3 (moderate)	Drug: RO4998452; 20mg po single dose
Experimental: 4 (severe)	Drug: RO4998452; 20mg po single dose

Outcome Measures

Primary Outcome Measures

1. Creatinine clearance; Pk parameters; adverse events [Days 1-3]

Secondary Outcome Measures

1. Blood glucose; meal tolerance test [Days 1-3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Renton	Washington	United States	98055
2		Moscow		Russian Federation	115419

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00933972
• Other Study ID Numbers: BP22321; 2008-008128-34
• First Posted: Jul 8, 2009
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 2, 2016