NCT01685502

Brief Summary

The objective of this study is to assess the efficacy and safety under practical use of Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1 year observation period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Typical duration for all trials

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

November 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

2.8 years

First QC Date

September 12, 2012

Last Update Submit

October 17, 2014

Conditions

Diabetes Mellitus

Keywords

Glucobay ODDiabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)

    Up to 1 year

  • Decrease rate of HbA1c

    Up to 1 year

Secondary Outcomes (1)

  • Body weight

    up to1 year

Study Arms (1)

Group 1

Patients treated with Glucobay OD under practical manner

Drug: Glucobay ODT (Acarbose, BAYG5421)

Interventions

Glucobay ODT (Acarbose, BAYG5421)DRUG

Patients treated with Glucobay OD under practical manner

Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Glucobay OD naive diabetics. Patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.

You may qualify if:

  • Glucobay OD naive diabetics. patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.

You may not qualify if:

  • Patients who are contraindicated based on the product label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Japan

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
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 14, 2012

Study Start

November 1, 2010

Primary Completion

September 1, 2013

Study Completion

August 1, 2014

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations

JP(1)