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CompletedNCT00909051Updated Jun 6, 2023

GlucoVIP - Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups

An observational study in Diabetes Mellitus, sponsored by Bayer. Completed at 16 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-06.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15,729
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetes Mellitus
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's enrollment of 15,729 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with untreated or pretreated diabetes mellitus or patients for which acarbose is indicated and without acarbose treatment within the last three months before study inclusion. The decision for treatment type and duration is taken by the investigator and is made before inclusion into the study.

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15,729 participants (actual)

Groups and cohorts

  • Group 1

    Drug: Acarbose (Glucobay, BAYG5421)

Interventions

06

What researchers measure

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)

    Time frame: During observation period of three months

07

Study locations

16 sites
  • Multiple Locations, Algeria
  • Multiple Locations, Bosnia and Herzegovina
  • Multiple Locations, Cambodia
  • Multiple Locations, China
  • Multiple Locations, Hong Kong
  • Multiple Locations, India
  • Multiple Locations, Indonesia
  • Multiple Locations, Korea, Republic of
  • Multiple Locations, Malaysia
  • Multiple Locations, Moldova, Republic of
  • Multiple Locations, Pakistan
  • Multiple Locations, Philippines
  • Multiple Locations, Russian Federation
  • Multiple Locations, Singapore
  • Multiple Locations, Thailand
  • Multiple Locations, Vietnam
08

References and documents

Publications

  • 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. PubMed 23435929 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2009 to primary completion in Dec 2010, 21 months.

Of 109 industry-sponsored observational studies under Diabetes Mellitus, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 39. This study's 21 months is close to that.

Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.

How these figures are worked out, and which studies are left out of them.

Registered
May 26, 2009
First posted
May 27, 2009
StartActual
Mar 24, 2009
Primary completionActual
Dec 31, 2010
CompletionActual
Dec 31, 2010
Last update
Jun 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00909051
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
May 27, 2009
Start date
Mar 24, 2009
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010
Last update
Jun 6, 2023

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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