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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01219582
First received: October 7, 2010
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Drug: Glucobay M (Acarbose/Metformin, BAY81-9783)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Open, Prospective, Multicentric, Single-arm, Non-interventional Study to Evaluate the Effectiveness & Safety of Oral Glucobay®-M Tablets in Type 2 Diabetes Patient

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change in fasting blood glucose levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in post-prandial glucose values [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Hemoglobin A1c (HbA1c) levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patient with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients with satisfaction of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 9364
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Type 2 Diabetes

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219582

Locations
India
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01219582     History of Changes
Other Study ID Numbers: 14954, GB0910IN
Study First Received: October 7, 2010
Last Updated: November 11, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by Bayer:
Diabetes Mellitus Type-2
Acarbose
Metformin
Drug Therapy, Combination

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014