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


Tracking Information

Start Date  ICMJEMay 2009
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
Original Primary Outcome Measures  ICMJE 
 (submitted: May 26, 2009)		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 ]
Change HistoryComplete list of historical versions of study NCT00909051 on ClinicalTrials.gov Archive Site

Descriptive Information

Brief Title  ICMJEGlucoVIP - Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups
Official Title  ICMJEDiabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups
Brief Summary

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

Detailed Description 
Study Phase 
Study Type  ICMJEObservational
Study Design  ICMJECohort, Prospective
Condition  ICMJEDiabetes Mellitus
Intervention  ICMJEDrug: Acarbose, Glucobay (BAYG5421)
Patients with diabetes type 2 newly treated with Glucobay
Study Arms / Comparison GroupsGroup 1
Intervention: Drug: Acarbose, Glucobay (BAYG5421)

Recruitment Information

Estimated Enrollment  ICMJE17000
Estimated Completion DateDecember 2010
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Bayer Clinical Trials Contactclinical-trials-contact@bayerhealthcare.com
Location Countries  ICMJEBosnia and Herzegovina,   Cambodia,   China,   Hong Kong,   India,   Indonesia,   Korea, Republic of,   Malaysia,   Moldova, Republic of,   Pakistan,   Philippines,   Russian Federation,   Singapore,   Thailand,   Vietnam

Administrative Information

NCT ID  ICMJENCT00909051
Responsible PartyMedical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
Study ID Numbers  ICMJE14284, GB 0701
Study Sponsor  ICMJEBayer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bayer Study DirectorBayer
Information Provided ByBayer