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

Primary Purpose

Diabetes Mellitus Type 2

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

RO4998452

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

1 (normal)

2 (mild)

3 (moderate)

4 (severe)

Arm Description

Outcomes

Primary Outcome Measures

Creatinine clearance; Pk parameters; adverse events

Secondary Outcome Measures

Blood glucose; meal tolerance test

Full Information

NCT ID

NCT00933972

First Posted

July 6, 2009

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00933972

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 (normal)

Arm Type

Experimental

Arm Title

2 (mild)

Arm Type

Experimental

Arm Title

3 (moderate)

Arm Type

Experimental

Arm Title

4 (severe)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

RO4998452

Intervention Description

20mg po single dose

Primary Outcome Measure Information:

Title

Creatinine clearance; Pk parameters; adverse events

Time Frame

Days 1-3

Secondary Outcome Measure Information:

Title

Blood glucose; meal tolerance test

Time Frame

Days 1-3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Renton

State/Province

Washington

ZIP/Postal Code

98055

Country

United States

City

Moscow

ZIP/Postal Code

115419

Country

Russian Federation

12. IPD Sharing Statement

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

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