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

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00933972

First received: July 6, 2009

Last updated: January 18, 2011

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 6, 2009

Last Updated Date

January 18, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00933972 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: RO4998452

20mg po single dose

Study Arm (s)

Experimental: 1 (normal)
Intervention: Drug: RO4998452
Experimental: 2 (mild)
Intervention: Drug: RO4998452
Experimental: 3 (moderate)
Intervention: Drug: RO4998452
Experimental: 4 (severe)
Intervention: Drug: RO4998452

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Russian Federation

Administrative Information

NCT Number ^ICMJE

NCT00933972

Other Study ID Numbers ^ICMJE

BP22321, 2008-008128-34

Has Data Monitoring Committee

Not Provided

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top