NCT01248481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
539

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

First QC Date

November 24, 2010

Last Update Submit

June 19, 2013

Conditions

Keywords

Acarbose/Glucobay®Basal insulinPPG (Postprandial Glycaemia)

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    After 20 weeks

Secondary Outcomes (2)

  • Duration and dose of acarbose treatment

    After 20 weeks

  • Postprandial Blood Glucose

    After 20 weeks

Study Arms (1)

Group 1

Drug: Acarbose (Glucobay, BAYG5421)

Interventions

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.

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with DM in korea

You may qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 25, 2010

Study Start

September 1, 2010

Study Completion

July 1, 2012

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations