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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00909051
First received: May 26, 2009
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

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:

Drug Information available for: Acarbose
U.S. FDA Resources

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

  Eligibility

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.
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909051

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov 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
Moldavia: 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013