Special Drug Use Investigation of Glucobay OD | NCT01685502

Studies
Special Drug Use Investigation of Glucobay OD

NCT01685502

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 20, 2014Estimated

Enrollment

2,289Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Glucobay ODT (Acarbose, BAYG5421)

Countries

Japan

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
Glucobay OD	Other Identifier	company internal

Status Module

Record Verification Date

Oct 2014

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

Nov 2010

Primary Completion Date

Sep 2013Actual

Completion Date

Aug 2014Actual

First Submitted Date

Sep 12, 2012

First Submission Date that Met QC Criteria

Sep 12, 2012

First Posted Date

Sep 14, 2012Estimated

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

Oct 17, 2014

Last Update Posted Date

Oct 20, 2014Estimated

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

The objective of this study is to assess the efficacy and safety under practical use of Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1 year observation period.

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

2,289Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients treated with Glucobay OD under practical manner	Drug: Glucobay ODT (Acarbose, BAYG5421)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucobay ODT (Acarbose, BAYG5421)	Drug	Patients treated with Glucobay OD under practical manner	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)		Up to 1 year
Decrease rate of HbA1c		Up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Body weight		up to1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Glucobay OD naive diabetics. patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.

Exclusion Criteria:

Patients who are contraindicated based on the product label

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

Glucobay OD naive diabetics. Patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.

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