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Special Drug Use Investigation of Glucobay OD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685502
First Posted: September 14, 2012
Last Update Posted: October 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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.

Condition Intervention
Diabetes Mellitus Drug: Glucobay ODT (Acarbose, BAYG5421)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Glucobay OD

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Body weight [ Time Frame: up to1 year ]

Enrollment: 2289
Study Start Date: November 2010
Study Completion Date: August 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Patients treated with Glucobay OD under practical manner
Drug: Glucobay ODT (Acarbose, BAYG5421)
Patients treated with Glucobay OD under practical manner

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685502


Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01685502     History of Changes
Other Study ID Numbers: 16517
Glucobay OD ( Other Identifier: company internal )
First Submitted: September 12, 2012
First Posted: September 14, 2012
Last Update Posted: October 20, 2014
Last Verified: October 2014

Keywords provided by Bayer:
Glucobay OD
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs