Special Drug Use Investigation of Glucobay OD

October 17, 2014 updated by: Bayer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2289

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

  • Japan
      • Many Locations, Japan

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Exclusion Criteria:

  • Patients who are contraindicated based on the product label

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
Patients treated with Glucobay OD under practical manner
Drug: Glucobay ODT (Acarbose, BAYG5421)
Patients treated with Glucobay OD under practical manner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)
Time Frame: Up to 1 year
Up to 1 year
Decrease rate of HbA1c
Time Frame: Up to 1 year
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: up to1 year
up to1 year

Collaborators and Investigators

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

Sponsor

Bayer

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

November 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (Estimate)

September 14, 2012

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 17, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16517
  • Glucobay OD (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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