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

NCT01219582 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9364

Last updated 2013-11-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-01-31
Completion
2012-12-31

Countries

  • India

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01219582 on ClinicalTrials.gov