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

June 5, 2023 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15729

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During observation period of three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2009

Primary Completion (Actual)

December 31, 2010

Study Completion (Actual)

December 31, 2010

Study Registration Dates

First Submitted

May 26, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimated)

May 27, 2009

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14284
  • GB0701 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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