GlucoFriend-evaluation the Effectiveness of Glucobay When... | NCT01248481

Studies
GlucoFriend-evaluation the Effectiveness of Glucobay When Combined With a Basal Insulin

NCT01248481

Sponsor

Bayer

Status

Completed

Last Update Posted

Jun 20, 2013Estimated

Enrollment

539Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Acarbose (Glucobay, BAYG5421)

Countries

South Korea

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
GB1010KR	Other Identifier	Company Internal

Status Module

Record Verification Date

Jun 2013

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

Sep 2010

Primary Completion Date

Not provided

Completion Date

Jul 2012Actual

First Submitted Date

Nov 24, 2010

First Submission Date that Met QC Criteria

Nov 24, 2010

First Posted Date

Nov 25, 2010Estimated

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

Jun 19, 2013

Last Update Posted Date

Jun 20, 2013Estimated

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

To evaluate the effectiveness of Glucobay when combined with a basal insulin under daily-life treatment conditions in a large sample of Korean patients.

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

539Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Acarbose (Glucobay, BAYG5421)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acarbose (Glucobay, BAYG5421)	Drug	Adult female and male patients are scheduled to be treated with acarbose will be enrolled after the therapy decision has been made. Physicians should consult the full prescribing information for Glucobay® before enrolling patients and familiarize themselves with the safety information in the product package label.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c		After 20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Duration and dose of acarbose treatment		After 20 weeks
Postprandial Blood Glucose		After 20 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent
Age ≥ 18 years
Diagnosed of type 2 diabetes for at least 6 months prior to enrollment
Patients treated with stable dose of a basal insulin (insulin glargine or insulin detemir) at least 2 months
HbA1C≥7.5 and ≤10.0%

Exclusion Criteria:

Exclusion criteria must be read in conjunction with the local product information

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with DM in korea

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020909	Acarbose

Ancestor Terms

ID	Term
D014312	Trisaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided