Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups
Scientific Title of Study
International, prospective, non-interventional observational study on effectiveness, safety and tolerability of Glucobay® in routine treatment of untreated or pretreated diabetes mellitus type 2/ Impaired Glucose Tolerance
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GB0701IN
Protocol Number
NCT00909051
ClinicalTrials.gov
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Not Applicable N/A
India
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr. Manish Garg
Designation
Affiliation
Country Medical Director India
Address
Bayer Pharmaceuticals Pvt. Ltd. Kolshet road Thane MAHARASHTRA 400607 India
Phone
022-25311448
Fax
022-25455080
Email
manish.garg@bayer.com
Details of Contact Person Public Query
Name
Dr. Manish Garg
Designation
Affiliation
Address
Bayer Pharmaceuticals Pvt. Ltd. Kolshet road Thane MAHARASHTRA 400607 India
Phone
022-25311448
Fax
022-25455080
Email
manish.garg@bayer.com
Source of Monetary or Material Support
Bayer Pharmaceutical Private Limited, Kolshet Road, Thane - 400607
India
All patients with untreated or pretreated diabetes mellitus type 2/ IGT can be included into the study.
No Glucobay® intake within the last 3 months before documentation of initial visit
ExclusionCriteria
Details
contraindication stated in the local Glucobay® product information; warnings and precautions
must be considered.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
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 ]
Secondary Outcome
Outcome
TimePoints
Nil
Nil
Target Sample Size
Total Sample Size="16000" Sample Size from India="" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
Date Missing
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
04/05/2009
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is international, prospective, non-interventional observational study, data are obtained on effectiveness, safety and tolerability of Glucobay® in routine treatment. The general study objectives are to investigate the influence of Glucobay® on fasting blood glucose, postprandial blood glucose (2h), HbA1C as well as the patients weight. Glucobay® (acarbose) is taken 1-3 times daily.A biometric evaluation - primarily descriptive and exploratory - will be carried out according to a statistical analysis
plan at the end of the study and summarized in a final report. All patients receiving at least one tablet will be included in the safety analysis. The results of this NIS study will be compared to the results of clinical trials.
The study is planned to be carried out in 2000 patients from 80 trial sites in India.FPFV for India - 21 JUNE 2010.