Diabetes Treatment With Glucobay in Combination With Sulfonylurea

NCT ID: NCT01613105

Last Updated: 2013-06-26

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

4564 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-12-31

Brief Summary

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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 sulfonylurea 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 sulfonylurea therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The Post Marketing Survelliance 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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Acarbose (Precose/Glucobay, BAYG5421)

Intervention Type DRUG

Oral Glucobay 25 titrated to Glucobay 50 upto three times a day with meals or as per investigators descretion.

Interventions

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Acarbose (Precose/Glucobay, BAYG5421)

Oral Glucobay 25 titrated to Glucobay 50 upto three times a day with meals or as per investigators descretion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* According to 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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Bayer Pharmaceuticals Pvt Ltd

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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GB0712IN

Identifier Type: OTHER

Identifier Source: secondary_id

13927

Identifier Type: -

Identifier Source: org_study_id

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