Special Drug Use Investigation of Glucobay OD

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucobay ODT (Acarbose, BAYG5421)

Drug

Patients treated with Glucobay OD under practical manner

Primary outcomes

Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)

Time frame: Up to 1 year
Decrease rate of HbA1c

Time frame: Up to 1 year

Secondary outcomes

Body weight

Time frame: up to1 year

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2014
First posted: Sep 14, 2012
Registry last updated: Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed