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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01219582

Acronym

GLOBE

Enrollment

9364

Registered

2010-10-13

Start date

2010-10-31

Completion date

2012-12-31

Last updated

2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Diabetes Mellitus Type-2, Acarbose, Metformin, Drug Therapy, Combination

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.

Interventions

DRUGGlucobay M (Acarbose/Metformin, BAY81-9783)

Oral Glucobay-M 25 every 8 hours (Q8H) titrated to Glucobay-M 50 Q8H or as per investigators discretion.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Number of patient with adverse events	12 weeks
Percentage of patients with satisfaction of treatment	12 weeks

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026