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NCT Number: NCT01219582

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucobay M (Acarbose/Metformin, BAY81-9783)

Drug

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

Primary outcomes

  1. Change in fasting blood glucose levels

    Time frame: 12 weeks

  2. Change in post-prandial glucose values

    Time frame: 12 weeks

  3. Change in Hemoglobin A1c (HbA1c) levels

    Time frame: 12 weeks

Secondary outcomes

  1. Number of patient with adverse events

    Time frame: 12 weeks

  2. Percentage of patients with satisfaction of treatment

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Open, Prospective, Multicentric, Single-arm, Non-interventional Study to Evaluate the Effectiveness & Safety of Oral Glucobay®-M Tablets in Type 2 Diabetes Patient

Acronym: GLOBE

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 13, 2010
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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