NCT00909051

Brief Summary

Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in a large sample of patients.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
15,729

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Geographic Reach
16 countries

16 active sites

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

March 24, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2010

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

May 26, 2009

Last Update Submit

June 5, 2023

Conditions

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Data collection on patients weight and waist circumference, fasting blood glucose, postprandial blood glucose (2h), HbA1C; exploratory analysis according to patient groups (concomitant cardiovascular disease groups, BMI)

    During observation period of three months

Study Arms (1)

Group 1

Drug: Acarbose (Glucobay, BAYG5421)

Interventions

Patients with diabetes type 2 newly treated with Glucobay

Group 1

Eligibility Criteria

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

* Patients with untreated or pretreated diabetes mellitus type 2 * No Glucobay® intake within the last 3 months before documentation of initial visit * Exclusion Criteria: contraindication stated in the local Glucobay® product information; warnings and precautions must be considered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Multiple Locations, Algeria

Location

Unknown Facility

Multiple Locations, Bosnia and Herzegovina

Location

Unknown Facility

Multiple Locations, Cambodia

Location

Unknown Facility

Multiple Locations, China

Location

Unknown Facility

Multiple Locations, Hong Kong

Location

Unknown Facility

Multiple Locations, India

Location

Unknown Facility

Multiple Locations, Indonesia

Location

Unknown Facility

Multiple Locations, Malaysia

Location

Unknown Facility

Multiple Locations, Moldova

Location

Unknown Facility

Multiple Locations, Pakistan

Location

Unknown Facility

Multiple Locations, Philippines

Location

Unknown Facility

Multiple Locations, Russia

Location

Unknown Facility

Multiple Locations, Singapore

Location

Unknown Facility

Multiple Locations, South Korea

Location

Unknown Facility

Multiple Locations, Thailand

Location

Unknown Facility

Multiple Locations, Vietnam

Location

Related Publications (1)

  • Zhang W, Kim D, Philip E, Miyan Z, Barykina I, Schmidt B, Stein H; Gluco VIP study. A multinational, observational study to investigate the efficacy, safety and tolerability of acarbose as add-on or monotherapy in a range of patients: the Gluco VIP study. Clin Drug Investig. 2013 Apr;33(4):263-74. doi: 10.1007/s40261-013-0063-3.

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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 27, 2009

Study Start

March 24, 2009

Primary Completion

December 31, 2010

Study Completion

December 31, 2010

Last Updated

June 6, 2023

Record last verified: 2023-06

Locations