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GLucobay M OBservation Study for Efficacy and Safety in Treatment of Type-2 Diabetes Patients

NCT ID: NCT01219582

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9364 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

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An observational and multicenter study to assess the effectiveness and safety of Glucobay®- M under daily life treatment of type-2 diabetes patients.The study objectives are to investigate the effectiveness and safety of Glucobay® -M on blood glucose and patients body - weight. Glucobay®- M is taken 1-3 times daily. All patients with type 2 diabetes mellitus, where investigator feels that addition of Glucobay®-M would be beneficial to patients will be included in non- interventional study. The routine investigation suggested by the attending physician will be done in diabetic patients. No additional investigation will be done for the study purpose. The uncontrolled diabetic patient on existing treatment and prescribed Glucobay®-M will be included in study after taking the informed consent. The patient will be asked to attend 2 follow up visit each after 6 weeks. All patients receiving at least one tablet will be included in the safety analysis.The study is planned to be carried out in 10000 patients from 320-350 trial sites in India.

Detailed Description

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Conditions

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Type 2 Diabetes

Keywords

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Diabetes Mellitus Type-2 Acarbose Metformin Drug Therapy, Combination

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Glucobay M (Acarbose/Metformin, BAY81-9783)

Intervention Type DRUG

Oral Glucobay-M 25 every 8 hours (Q8H) titrated to Glucobay-M 50 Q8H or as per investigators discretion.

Interventions

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Glucobay M (Acarbose/Metformin, BAY81-9783)

Oral Glucobay-M 25 every 8 hours (Q8H) titrated to Glucobay-M 50 Q8H or as per investigators discretion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female and male patients ≥ 18 years of age with Type 2 Diabetes where investigator feels that addition of Glucobay®-M would be beneficial to patients.
* The diagnosis will be made based on the ADA criteria by the attending physician.
* Patients will be defined as included in the study if they have a documented prescription of Glucobay-M by the physician.
* Patients willing to provide signed \& dated informed consent.
* Patients willing to comply with study requirements.

Exclusion Criteria

* According to the local product information
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , India

Site Status

Countries

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India

Other Identifiers

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GB0910IN

Identifier Type: OTHER

Identifier Source: secondary_id

14954

Identifier Type: -

Identifier Source: org_study_id