Diabetes MellitusNCT01248481
GlucoFriend-evaluation the Effectiveness of Glucobay When Combined With a Basal Insulin
An observational study of Diabetes Mellitus, run by Bayer at 1 site in South Korea.
Trial summary
To evaluate the effectiveness of Glucobay when combined with a basal insulin under daily-life treatment conditions in a large sample of Korean 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
- 539 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Jul 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: Patients with DM in korea
Who may be able to join
- Signed written informed consent
- Age ≥ 18 years
- Diagnosed of type 2 diabetes for at least 6 months prior to enrollment
- Patients treated with stable dose of a basal insulin (insulin glargine or insulin detemir) at least 2 months
- HbA1C≥7.5 and ≤10.0%
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Use of a Basal Insulin and Glucobay For Reducing PPG to End Diabetes Progress
To evaluate the effectiveness of Glucobay when combined with a basal insulin under daily-life treatment conditions in a large sample of Korean patients.
- Conditions
- Diabetes Mellitus
- Being tested
- Acarbose (Glucobay, BAYG5421)
- Keywords
- Acarbose/Glucobay®, Basal insulin, PPG (Postprandial Glycaemia)
- 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
Adult female and male patients are scheduled to be treated with acarbose will be enrolled after the therapy decision has been made. Physicians should consult the full prescribing information for Glucobay® before enrolling patients and familiarize themselves with the safety information in the product package label.
| 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.
Change in HbA1c
Measured: After 20 weeks
Secondary outcomes (2)
Duration and dose of acarbose treatment
Measured: After 20 weeks
Postprandial Blood Glucose
Measured: After 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startSep 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Time perspective
- Prospective
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248481
- Sponsor's protocol ID
- 15316
- Other IDs
- GB1010KR
- Status last verified
- Jun 2013
- First submitted
- 24 Nov 2010
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of a Basal Insulin and Glucobay For Reducing PPG to End Diabetes Progress
- ClinicalTrials.gov ID
- NCT01248481
- Acronym / sponsor ID
- 15316
- Conditions
- Diabetes Mellitus
- Keywords
- Acarbose/Glucobay®, Basal insulin, PPG (Postprandial Glycaemia)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Nov 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.
To evaluate the effectiveness of Glucobay when combined with a basal insulin under daily-life treatment conditions in a large sample of Korean patients.
Study design
- 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 DM in korea
Key inclusion criteria (5 listed)
- Signed written informed consent
- Age ≥ 18 years
- Diagnosed of type 2 diabetes for at least 6 months prior to enrollment
- Patients treated with stable dose of a basal insulin (insulin glargine or insulin detemir) at least 2 months
- HbA1C≥7.5 and ≤10.0%
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)Adult female and male patients are scheduled to be treated with acarbose will be enrolled after the therapy decision has been made. Physicians should consult the full prescribing information for Glucobay® before enrolling patients and familiarize themselves with the safety information in the product package label. | Drug | Group 1 |
Primary outcome
Change in HbA1c
Time frame: After 20 weeks
2 secondary outcomes
Duration and dose of acarbose treatment
Time frame: After 20 weeks
Postprandial Blood Glucose
Time frame: After 20 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 20 Jun 2013.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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 Diabetes Mellitus, run by Bayer at 1 site in South Korea.
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 20 Jun 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 South Korea. 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 HbA1c (time frame: After 20 weeks). 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 20 Jun 2013.