Diabetes Treatment With Glucobay in Combination With Metf... | NCT01612741

Studies
Diabetes Treatment With Glucobay in Combination With Metformin

NCT01612741

Sponsor

Bayer

Status

Completed

Last Update Posted

Jul 8, 2014Estimated

Enrollment

19,509Actual

Phase

Not provided

Conditions

Type 2 Diabetes Mellitus

Interventions

Acarbose (Precose/Glucobay, BAYG5421)

Countries

India

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
GB0711IN	Other Identifier	company internal

Status Module

Record Verification Date

Jul 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

Apr 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jun 4, 2012

First Submission Date that Met QC Criteria

Jun 4, 2012

First Posted Date

Jun 6, 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

Jul 7, 2014

Last Update Posted Date

Jul 8, 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

In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of metformin under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing metformin therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The PMS study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.

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

19,509Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acarbose (Precose/Glucobay, BAYG5421)	Drug	Oral Glucobay 25 titrated to Glucobay 50 three times a day with meals or as per investigators descretion.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Data collection on body weight		16 weeks
Data collection on blood glucose		16 weeks
Data collection on Hba1c		16 weeks
Data collection on pre treatment concomitant diseases		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety variables will be summarized using descriptive statistics based on adverse events collection		16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patient with type 2 diabetes with one of the following treatment ongoing : 1) Metformin 2) Metformin + OHA.
In such patients, if investigator feels that addition of acarbose would be benficial for the patients

Exclusion Criteria:

According to 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

Type 2 diabetes

Sampling Method

Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
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