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

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Glucobay M (Acarbose/Metformin, BAY81-9783)

• Registration Number: NCT01219582
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-11
• Study First Posted: 2010-10-13
• Primary Completion: 2012-01
• Study Completion: 2012-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9364

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.

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Exclusion Criteria

• According to the local product information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Glucobay M (Acarbose/Metformin, BAY81-9783)	-

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c (HbA1c) levels	12 weeks
Change in fasting blood glucose levels	12 weeks
Change in post-prandial glucose values	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of patient with adverse events	12 weeks
Percentage of patients with satisfaction of treatment	12 weeks