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

Type 2 Diabetes Clinical Trial

— GLOBE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219582
• Other study ID #: 14954
• Secondary ID: GB0910IN
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: November 11, 2013
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9364
• Est. completion date: December 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fasting blood glucose levels		12 weeks	No
Primary	Change in post-prandial glucose values		12 weeks	No
Primary	Change in Hemoglobin A1c (HbA1c) levels		12 weeks	No
Secondary	Number of patient with adverse events		12 weeks	Yes
Secondary	Percentage of patients with satisfaction of treatment		12 weeks	No

External Links

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