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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01248481
First received: November 24, 2010
Last updated: June 19, 2013
Last verified: June 2013
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration and dose of acarbose treatment [ Time Frame: After 20 weeks ] [ Designated as safety issue: No ]
  • Postprandial Blood Glucose [ Time Frame: After 20 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Country Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01248481     History of Changes
Other Study ID Numbers: 15316, GB1010KR
Study First Received: November 24, 2010
Last Updated: June 19, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014