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NCT01248481 Clinical Trial

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

Diabetes Mellitus Clinical Trial

Official title:
Combined Use of a Basal Insulin and Glucobay For Reducing PPG to End Diabetes Progress

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01248481
Other study ID # 15316
Secondary ID GB1010KR
Status Completed
Phase N/A
First received November 24, 2010
Last updated June 19, 2013
Start date September 2010
Est. completion date July 2012

Study information
Verified date June 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial Summary

To evaluate the effectiveness of Glucobay when combined with a basal insulin under daily-life treatment conditions in a large sample of Korean patients.

Recruitment information / eligibility
Status Completed
Enrollment 539
Est. completion date July 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c After 20 weeks No
Secondary Duration and dose of acarbose treatment After 20 weeks No
Secondary Postprandial Blood Glucose After 20 weeks No
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