Trial Condition(s):
Type 2 diabetes
GLucobay M OBservation study for Efficacy and safety in treatment of type-2 diabetes patients (GLOBE)
Bayer Identifier:
14954
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, India | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open, Prospective, multicentric, single-arm, non-interventional study to evaluate the effectiveness & safety of oral Glucobay®-M tablets in type 2 diabetes patient
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Change in fasting blood glucose levelsTimeframe: 12 weeks
- Change in post-prandial glucose valuesTimeframe: 12 weeks
- Change in Hemoglobin A1c (HbA1c) levelsTimeframe: 12 weeks
Secondary Outcome
- Number of patient with adverse eventsTimeframe: 12 weeks
- Percentage of patients with satisfaction of treatmentTimeframe: 12 weeks
Additional Information
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