Special Drug Use Investigation of Glucobay OD

Bayer0 sites2,289 target enrollmentNovember 2010

ConditionsDiabetes Mellitus

InterventionsGlucobay ODT (Acarbose, BAYG5421)

DrugsGlucobay ODT (Acarbose, BAYG5421)

Overview

Phase: Not Applicable
Intervention: Glucobay ODT (Acarbose, BAYG5421)
Conditions: Diabetes Mellitus
Sponsor: Bayer
Enrollment: 2289
Primary Endpoint: Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of this study is to assess the efficacy and safety under practical use of Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1 year observation period.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

August 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Glucobay OD naive diabetics. patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.