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

NCT ID: NCT00933972

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 (normal)

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

20mg po single dose

2 (mild)

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

20mg po single dose

3 (moderate)

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

20mg po single dose

4 (severe)

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

20mg po single dose

Interventions

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RO4998452

20mg po single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Renton, Washington, United States

Site Status

Moscow, , Russia

Site Status

Countries

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United States Russia

Other Identifiers

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2008-008128-34

Identifier Type: -

Identifier Source: secondary_id

BP22321

Identifier Type: -

Identifier Source: org_study_id