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

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Acarbose (Glucobay, BAYG5421)

• Registration Number: NCT01248481
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Study Completion: 2012-07
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 539

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%

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Acarbose (Glucobay, BAYG5421)	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	After 20 weeks

Secondary Outcome Measures

Name	Time	Method
Duration and dose of acarbose treatment	After 20 weeks
Postprandial Blood Glucose	After 20 weeks