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

This study is currently recruiting participants.

Verified by Hoffmann-La Roche, August 2009

First Received: July 6, 2009 Last Updated: August 26, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00933972

Purpose

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	Intervention	Phase
Diabeles Mellitus, Type 2	Drug: RO4998452	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Creatinine clearance; Pk parameters; adverse events [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood glucose; meal tolerance test [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	June 2009
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
1 (normal): Experimental	Drug: RO4998452 20mg po single dose
2 (mild): Experimental	Drug: RO4998452 20mg po single dose
3 (moderate): Experimental	Drug: RO4998452 20mg po single dose
4 (severe): Experimental	Drug: RO4998452 20mg po single dose

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933972

Contacts

Contact: Please reference Study ID Number: BP22321	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

United States, Washington
	Recruiting
RENTON, Washington, United States, 98055
Russian Federation
	Recruiting
MOSCOW, Russian Federation, 115419

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BP22321, 2008-008128-34
Study First Received:	July 6, 2009
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00933972 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009