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Special Drug Use Investigation of Glucobay OD

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ClinicalTrials.gov Identifier: NCT01685502
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Drug: Glucobay ODT (Acarbose, BAYG5421)

Study Type : Observational
Actual Enrollment : 2289 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Glucobay OD
Study Start Date : November 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs) [ Time Frame: Up to 1 year ]
  2. Decrease rate of HbA1c [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. Body weight [ Time Frame: up to1 year ]


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

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01685502     History of Changes
Other Study ID Numbers: 16517
Glucobay OD ( Other Identifier: company internal )
First Posted: September 14, 2012    Key Record Dates
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