check_circleStudy Completed

Type 2 diabetes

Bayer Identifier:

14954

ClinicalTrials.gov Identifier:

NCT01219582

EudraCT Number:

Not Available

EU CT Number:

Not Available
GLucobay M OBservation study for Efficacy and safety in treatment of type-2 diabetes patients

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

Trial summary

Enrollment Goal
9364
Trial Dates
October 2010 - December 2012
Phase
N/A
Could I Receive a placebo
No
Products
Glucobay M (Acarbose/Metformin, BAY81-9783)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, India

Primary Outcome

  • Change in fasting blood glucose levels
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change in post-prandial glucose values
    date_rangeTime Frame:
    12 weeks
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    Safety Issue:
    No
  • Change in Hemoglobin A1c (HbA1c) levels
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of patient with adverse events
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of patients with satisfaction of treatment
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

Open, Prospective, multicentric, single-arm, non-interventional study to evaluate the effectiveness & safety of oral Glucobay®-M tablets in type 2 diabetes patient
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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