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

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ClinicalTrials.gov Identifier: NCT00909051
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : January 19, 2012
Sponsor:
Information provided by:
Bayer

Brief Summary:
Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in a large sample of patients.

Condition or disease Intervention/treatment
Diabetes Mellitus Drug: Acarbose (Glucobay, BAYG5421)

Study Type : Observational
Actual Enrollment : 15729 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups
Study Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
Group 1 Drug: Acarbose (Glucobay, BAYG5421)
Patients with diabetes type 2 newly treated with Glucobay



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00909051     History of Changes
Other Study ID Numbers: 14284
GB0701 ( Other Identifier: Company internal )
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by Bayer:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs