Type 2 DiabetesGLOBENCT01219582
GLucobay M OBservation Study for Efficacy and Safety in Treatment of Type-2 Diabetes Patients
An observational study of Type 2 Diabetes, run by Bayer at 1 site in India.
Trial summary
An observational and multicenter study to assess the effectiveness and safety of Glucobay®- M under daily life treatment of type-2 diabetes patients.The study objectives are to investigate the effectiveness and safety of Glucobay® -M on blood glucose and patients body - weight. Glucobay®- M is taken 1-3 times daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Glucobay M (Acarbose/Metformin, BAY81-9783)
- Type of treatment
- Pill or oral medicine
- How many people
- 9,364 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2010to Dec 2012
- 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: Type 2 Diabetes
Who may be able to join
- Female and male patients ≥ 18 years of age with Type 2 Diabetes where investigator feels that addition of Glucobay®-M would be beneficial to patients.
- The diagnosis will be made based on the ADA criteria by the attending physician.
- Patients will be defined as included in the study if they have a documented prescription of Glucobay-M by the physician.
- Patients willing to provide signed \& dated informed consent.
- Patients willing to comply with study requirements.
Who cannot join
- According to the local product information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Prospective, Multicentric, Single-arm, Non-interventional Study to Evaluate the Effectiveness & Safety of Oral Glucobay®-M Tablets in Type 2 Diabetes Patient
An observational and multicenter study to assess the effectiveness and safety of Glucobay®- M under daily life treatment of type-2 diabetes patients.The study objectives are to investigate the effectiveness and safety of Glucobay® -M on blood glucose and patients body - weight. Glucobay®- M is taken 1-3 times daily. All patients with type 2 diabetes mellitus, where investigator feels that addition of Glucobay®-M would be beneficial to patients will be included in non- interventional study. The routine investigation suggested by the attending physician will be done in diabetic patients. No additional investigation will be done for the study purpose. The uncontrolled diabetic patient on existing treatment and prescribed Glucobay®-M will be included in study after taking the informed consent. The patient will be asked to attend 2 follow up visit each after 6 weeks. All patients receiving at least one tablet will be included in the safety analysis.The study is planned to be carried out in 10000 patients from 320-350 trial sites in India.
- Conditions
- Type 2 Diabetes
- Being tested
- Glucobay M (Acarbose/Metformin, BAY81-9783)
- Keywords
- Diabetes Mellitus Type-2, Acarbose, Metformin, Drug Therapy, Combination
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucobay M (Acarbose/Metformin, BAY81-9783)Drug
Oral Glucobay-M 25 every 8 hours (Q8H) titrated to Glucobay-M 50 Q8H or as per investigators discretion.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Glucobay M (Acarbose/Metformin, BAY81-9783) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting blood glucose levels
Measured: 12 weeks
Change in post-prandial glucose values
Measured: 12 weeks
Change in Hemoglobin A1c (HbA1c) levels
Measured: 12 weeks
Secondary outcomes (2)
Number of patient with adverse events
Measured: 12 weeks
Percentage of patients with satisfaction of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 9,364 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
- NCT01219582
- Sponsor's protocol ID
- 14954
- Other IDs
- GB0910IN
- Acronym
- GLOBE
- Status last verified
- Nov 2013
- First submitted
- 7 Oct 2010
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Prospective, Multicentric, Single-arm, Non-interventional Study to Evaluate the Effectiveness & Safety of Oral Glucobay®-M Tablets in Type 2 Diabetes Patient
- ClinicalTrials.gov ID
- NCT01219582
- Acronym / sponsor ID
- GLOBE / 14954
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Mellitus Type-2, Acarbose, Metformin, Drug Therapy, Combination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,364 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Oct 2010 (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.
An observational and multicenter study to assess the effectiveness and safety of Glucobay®- M under daily life treatment of type-2 diabetes patients.The study objectives are to investigate the effectiveness and safety of Glucobay® -M on blood glucose and patients body - weight. Glucobay®- M is taken 1-3 times daily. All patients with type 2 diabetes mellitus, where investigator feels that addition of Glucobay®-M would be beneficial to patients will be included in non- interventional study. The routine investigation suggested by the attending physician will be done in diabetic patients. No additional investigation will be done for the study purpose. The uncontrolled diabetic patient on existing treatment and prescribed Glucobay®-M will be included in study after taking the informed consent. The patient will be asked to attend 2 follow up visit each after 6 weeks. All patients receiving at least one tablet will be included in the safety analysis.The study is planned to be carried out in 10000 patients from 320-350 trial sites in India.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Glucobay M (Acarbose/Metformin, BAY81-9783) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetes
Key inclusion criteria (5 listed)
- Female and male patients ≥ 18 years of age with Type 2 Diabetes where investigator feels that addition of Glucobay®-M would be beneficial to patients.
- The diagnosis will be made based on the ADA criteria by the attending physician.
- Patients will be defined as included in the study if they have a documented prescription of Glucobay-M by the physician.
- Patients willing to provide signed \& dated informed consent.
- Patients willing to comply with study requirements.
Key exclusion criteria (1 listed)
- According to 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 |
|---|---|---|
| Glucobay M (Acarbose/Metformin, BAY81-9783)Oral Glucobay-M 25 every 8 hours (Q8H) titrated to Glucobay-M 50 Q8H or as per investigators discretion. | Drug | Group 1 |
Primary outcome
Change in fasting blood glucose levels
Time frame: 12 weeks
Change in post-prandial glucose values
Time frame: 12 weeks
Change in Hemoglobin A1c (HbA1c) levels
Time frame: 12 weeks
2 secondary outcomes
Number of patient with adverse events
Time frame: 12 weeks
Percentage of patients with satisfaction of treatment
Time frame: 12 weeks
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 13 Nov 2013.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Bayer at 1 site in India.
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 5 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 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Change in fasting blood glucose levels (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2013.