Diabetes MellitusNCT00909051
GlucoVIP - Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups
An observational study of Diabetes Mellitus, run by Bayer at 16 sites in 16 countries.
Trial summary
Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in a large sample of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Acarbose (Glucobay, BAYG5421)
- How many people
- 15,729 participants
- Where
- 16 sitesin 16 countries
- Study dates
- 24 Mar 2009to 31 Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information.
Trial locations and contacts
16 sites in 16 countries.
16 sites in 16 countries
About this study
Official title: Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups
Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in a large sample of patients.
- Conditions
- Diabetes Mellitus
- Being tested
- Acarbose (Glucobay, BAYG5421)
- Keywords
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acarbose (Glucobay, BAYG5421)Drug
Patients with diabetes type 2 newly treated with Glucobay
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Acarbose (Glucobay, BAYG5421) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During observation period of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study start24 Mar 2009
- Primary completion31 Dec 2010
- Study completion31 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909051
- Sponsor's protocol ID
- 14284
- Other IDs
- GB0701
- Status last verified
- Jun 2023
- First submitted
- 26 May 2009
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups
- ClinicalTrials.gov ID
- NCT00909051
- Acronym / sponsor ID
- 14284
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,729 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2009 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 Dec 2010 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in a large sample of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Acarbose (Glucobay, BAYG5421) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the local product information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acarbose (Glucobay, BAYG5421)Patients with diabetes type 2 newly treated with Glucobay | Drug | Group 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Results publication: PubMed 23435929Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
16 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Bayer at 16 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Algeria, Bosnia and Herzegovina, Cambodia, China, Hong Kong and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00909051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.