GLucobay M OBservation Study for Efficacy and Safety in Treatment of Type-2 Diabetes Patients (GLOBE)
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||October 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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.