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GlucoFriend-evaluation the Effectiveness of Glucobay When Combined With a Basal Insulin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01248481
First Posted: November 25, 2010
Last Update Posted: June 20, 2013
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:
Bayer
  Purpose
To evaluate the effectiveness of Glucobay when combined with a basal insulin under daily-life treatment conditions in a large sample of Korean patients.

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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Combined Use of a Basal Insulin and Glucobay For Reducing PPG to End Diabetes Progress

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: After 20 weeks ]

Secondary Outcome Measures:
  • Duration and dose of acarbose treatment [ Time Frame: After 20 weeks ]
  • Postprandial Blood Glucose [ Time Frame: After 20 weeks ]

Enrollment: 539
Study Start Date: September 2010
Study Completion Date: July 2012
Groups/Cohorts Assigned Interventions
Group 1 Drug: Acarbose (Glucobay, BAYG5421)
Adult female and male patients are scheduled to be treated with acarbose will be enrolled after the therapy decision has been made. Physicians should consult the full prescribing information for Glucobay® before enrolling patients and familiarize themselves with the safety information in the product package label.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with DM in korea
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Age ≥ 18 years
  • Diagnosed of type 2 diabetes for at least 6 months prior to enrollment
  • Patients treated with stable dose of a basal insulin (insulin glargine or insulin detemir) at least 2 months
  • HbA1C≥7.5 and ≤10.0%

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information
  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): NCT01248481


Locations
Korea, Republic of
Many Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Country Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01248481     History of Changes
Other Study ID Numbers: 15316
GB1010KR ( Other Identifier: Company Internal )
First Submitted: November 24, 2010
First Posted: November 25, 2010
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by Bayer:
Acarbose/Glucobay®
Basal insulin
PPG (Postprandial Glycaemia)

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