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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Glucobay M (Acarbose/Metformin, BAY81-9783)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Glucobay M (Acarbose/Metformin, BAY81-9783)<br>* Oral Glucobay-M 25 every 8 hours (Q8H) titrated to Glucobay-M 50 Q8H or as per investigators discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting blood glucose levels |  | 12 weeks | 
| Change in post-prandial glucose values |  | 12 weeks | 
| Change in Hemoglobin A1c (HbA1c) levels |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with adverse events |  | 12 weeks | 
| Percentage of patients with satisfaction of treatment |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus Type-2, Acarbose, Metformin, Drug Therapy, Combination