GlucoVIP - Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups

This study has been completed.
Information provided by:
Bayer Identifier:
First received: May 26, 2009
Last updated: January 18, 2012
Last verified: January 2012
Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in a large sample of patients.

Condition Intervention
Diabetes Mellitus
Drug: Acarbose (Glucobay, BAYG5421)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Data collection on patients weight and waist circumference, fasting blood glucose, postprandial blood glucose (2h), HbA1C; exploratory analysis according to patient groups (concomitant cardiovascular disease groups, BMI) [ Time Frame: During observation period of three months ] [ Designated as safety issue: No ]

Enrollment: 15729
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Acarbose (Glucobay, BAYG5421)
Patients with diabetes type 2 newly treated with Glucobay


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Patients with untreated or pretreated diabetes mellitus type 2
  • No Glucobay® intake within the last 3 months before documentation of initial visit
  • Exclusion Criteria: contraindication stated in the local Glucobay® product information; warnings and precautions must be considered.

Inclusion Criteria:

  • Patients with untreated or pretreated diabetes mellitus or patients for which acarbose is indicated and without acarbose treatment within the last three months before study inclusion. The decision for treatment type and duration is taken by the investigator and is made before inclusion into the study.

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00909051

Many Locations, Algeria
Bosnia and Herzegovina
Many Locations, Bosnia and Herzegovina
Many Locations, Cambodia
Many Locations, China
Hong Kong
Many Locations, Hong Kong
Many Locations, India
Many Locations, Indonesia
Korea, Republic of
Many Locations, Korea, Republic of
Many Locations, Malaysia
Moldova, Republic of
Many Locations, Moldova, Republic of
Many Locations, Pakistan
Many Locations, Philippines
Russian Federation
Many Locations, Russian Federation
Many Locations, Singapore
Many Locations, Thailand
Many Locations, Vietnam
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT00909051     History of Changes
Other Study ID Numbers: 14284  GB0701 
Study First Received: May 26, 2009
Last Updated: January 18, 2012
Health Authority: Bosnia: Federal Ministry of Health
Cambodia: Ministry of Health
China: Ethics Committee
Hong Kong: Ethics Committee
India: Ministry of Health
Indonesia: National Agency of Drug and Food Control
Korea: Food and Drug Administration
Malaysia: Medical Research Ethics Committee (MREC)
Malaysia: Ministry of Health
Moldova: Ministry of Health
Pakistan: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Singapore: Domain Specific Review Boards
Thailand: Ethical Committee
Vietnam: Ministry of Health
Philippines: Bureau of Food and Drugs
Philippines: Department of Health
Algeria: Ministry of Health

Keywords provided by Bayer:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Enzyme Inhibitors
Glycoside Hydrolase Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 30, 2016