A Study of RO4998452 in Type 2 Diabetes Patients With Var... | NCT00933972

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

NCT00933972

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

36Actual

Phase

Phase 1

Conditions

Diabetes Mellitus Type 2

Interventions

RO4998452

Countries

United States
Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-008128-34

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jul 6, 2009

First Submission Date that Met QC Criteria

Jul 7, 2009

First Posted Date

Jul 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RO4998452	Drug	20mg po single dose	1 (normal) 2 (mild) 3 (moderate) 4 (severe)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Creatinine clearance; Pk parameters; adverse events		Days 1-3

Secondary Outcomes

Measure	Description	Time Frame
Blood glucose; meal tolerance test		Days 1-3

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Renton	Washington	98055	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided