Evaluation of Diabetes Care at Austrian GPs | NCT00979394

Studies
Evaluation of Diabetes Care at Austrian GPs

NCT00979394

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Aug 17, 2010Estimated

Enrollment

1,513Actual

Phase

Not provided

Conditions

Type 2 Diabetes

Interventions

Not provided

Countries

Not provided

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

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Sep 17, 2009

First Submission Date that Met QC Criteria

Sep 17, 2009

First Posted Date

Sep 18, 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

Aug 16, 2010

Last Update Posted Date

Aug 17, 2010Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This registery should show the medical care of patient with Type 2 Diabetes (T2D) at GP-offices. Furthermore data of co morbidities and risk factors should be evaluated. Objectives of this NIS (cross-sectional study) are:

To evaluate which characteristics or co-morbidities are being existent for patient with T2D at GP level,
To evaluate representative profile of patient with T2D in Austria,
To evaluate which medical therapies are used.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,513Actual

Label	Type	Description	Intervention Names
Patients with type 2 diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate characteristics or co morbidities being existent for patient with T2D at GP		Once per patient

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes mellitus type II

Exclusion Criteria:

Diabetes mellitus type I
Gestation diabetes
Induced diabetes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

GPs

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernhard Ludvig	General Hospital Vienna	Study Chair
Guntram Schernthaner	Krankenanstalt Rudolfsstiftung	Study Chair

Locations

Not provided

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