GLucobay M OBservation Study for Efficacy and Safety in Treatment of Type-2 Diabetes Patients (GLOBE)
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|ClinicalTrials.gov Identifier: NCT01219582|
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : November 13, 2013
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|Condition or disease||Intervention/treatment|
|Type 2 Diabetes||Drug: Glucobay M (Acarbose/Metformin, BAY81-9783)|
|Study Type :||Observational|
|Actual Enrollment :||9364 participants|
|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|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||December 2012|
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.
- Change in fasting blood glucose levels [ Time Frame: 12 weeks ]
- Change in post-prandial glucose values [ Time Frame: 12 weeks ]
- Change in Hemoglobin A1c (HbA1c) levels [ Time Frame: 12 weeks ]
- Number of patient with adverse events [ Time Frame: 12 weeks ]
- Percentage of patients with satisfaction of treatment [ Time Frame: 12 weeks ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
- According to the local product information
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219582
|Many Locations, India|
|Study Director:||Bayer Study Director||Bayer|
|Other Study ID Numbers:||
GB0910IN ( Other Identifier: company internal )
|First Posted:||October 13, 2010 Key Record Dates|
|Last Update Posted:||November 13, 2013|
|Last Verified:||November 2013|
Diabetes Mellitus Type-2
Drug Therapy, Combination
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Molecular Mechanisms of Pharmacological Action