Diabetes MellitusPhase 4NCT00858676
Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)
A Phase 4 study testing acarbose in people with Diabetes Mellitus and Impaired Glucose Tolerance, run by Aichi Gakuin University at 1 site in Japan.
Trial summary
The objective of this trial is to investigate the effect of early treatment of glucose toxicity with acarbose, a drug to control postprandial hyperglycemia, on the occurence of cardiovascular events and the inhibition of atherosclerosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Impaired Glucose Tolerance, Coronary Artery Disease
- What is being tested?
- acarbose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2009to Mar 2013
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed with coronary artery disease, with type 2 diabetes or impaired glucose tolerance
Who cannot join
- Patients scheduled to undergo revascularization at the time of enrollment
- Patients who are being treated with an oral hypoglycemic drug or an insulin preparation
- Patients with a history of laparotomy of ileus
- Pre- and postoperative patients or individuals with severe infection or serious trauma
- Patients with gastrointestinal disorders such as diarrhea and vomiting
- Patients with a history of hypersensitivity to acarbose
- Pregnant or possibly pregnant women
- Patients who are judged by the attending physician to be otherwise ineligible
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
Nagoya, 464-8650
Tatsuaki Matsubara, MD, PhD, +81-52-759-2111
Tatsuaki Matsubara, MD, PhD
About this study
Official title: Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation
The objective of this trial is to investigate the effect of early treatment of glucose toxicity with acarbose, a drug to control postprandial hyperglycemia, on the occurence of cardiovascular events and the inhibition of atherosclerosis.
Read the detailed description
Acarbose suppresses the postprandial increase in plasma glucose levels by inhibiting the activities of alpha-amylase and alpha-glucosidase involved in digestion and absorption of carbohydrates in the intestine. A clinical study involving patients with type 2 diabetes demonstrated that acarbose decreased the post-load glucose level and improved glycosylated hemoglobin control. A prospective study involving patients with impaired glucose tolerance (IGT) demonstrated that acarbose inhibited progression to type 2 diabetes and significantly reduced the risk of cardiovascular diseases. It has also been reported that acarbose slows increase in the intima-media thickness and inhibits the progression of atherosclerosis. A significant proportion of patients with acute coronary syndrome and those with stable angina pectoris suffer from diabetes or IGT, and their prognosis is poor.
- Being tested
- acarbose
- Keywords
- acarbose, diabetes mellitus, impaired glucose tolerance, coronary artery disease
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acarboseDrug
Also called Glucobay
50mg acarbose 3 times a day PO. duration: one year
| Study group | Role | What they receive |
|---|---|---|
| Acarbose | Active comparator | Not described Receives: Drug: acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2012
- Study completionMar 2013 (estimated)
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aichi Gakuin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatsuaki Matsubara, MD, PhD, Aichi Gakuin University
- Investigators
- Tatsuaki Matsubara, MD, PhD, Principal investigator, Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858676
- Sponsor's protocol ID
- AGU-75
- Status last verified
- Jul 2012
- First submitted
- 9 Mar 2009
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation
- ClinicalTrials.gov ID
- NCT00858676
- Acronym / sponsor ID
- AGU-75
- Keywords
- acarbose, diabetes mellitus, impaired glucose tolerance, coronary artery disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aichi Gakuin UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (estimated)
- First posted
- 10 Mar 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.
The objective of this trial is to investigate the effect of early treatment of glucose toxicity with acarbose, a drug to control postprandial hyperglycemia, on the occurence of cardiovascular events and the inhibition of atherosclerosis.
Detailed description
Acarbose suppresses the postprandial increase in plasma glucose levels by inhibiting the activities of alpha-amylase and alpha-glucosidase involved in digestion and absorption of carbohydrates in the intestine. A clinical study involving patients with type 2 diabetes demonstrated that acarbose decreased the post-load glucose level and improved glycosylated hemoglobin control. A prospective study involving patients with impaired glucose tolerance (IGT) demonstrated that acarbose inhibited progression to type 2 diabetes and significantly reduced the risk of cardiovascular diseases. It has also been reported that acarbose slows increase in the intima-media thickness and inhibits the progression of atherosclerosis. A significant proportion of patients with acute coronary syndrome and those with stable angina pectoris suffer from diabetes or IGT, and their prognosis is poor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acarbose | Active comparator | Drug: acarbose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have been diagnosed with coronary artery disease, with type 2 diabetes or impaired glucose tolerance
Key exclusion criteria (8 listed)
- Patients scheduled to undergo revascularization at the time of enrollment
- Patients who are being treated with an oral hypoglycemic drug or an insulin preparation
- Patients with a history of laparotomy of ileus
- Pre- and postoperative patients or individuals with severe infection or serious trauma
- Patients with gastrointestinal disorders such as diarrhea and vomiting
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 |
|---|---|---|
| acarboseAlso: Glucobay50mg acarbose 3 times a day PO. duration: one year | Drug | Acarbose |
Primary outcome
sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
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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.
Tatsuaki Matsubara, MD, PhD principal investigator
Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acarbose in people with Diabetes Mellitus and Impaired Glucose Tolerance, run by Aichi Gakuin University at 1 site in Japan.
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 8 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: status not confirmed, as of the sponsor's last update on 18 Jul 2012. 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 Japan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatsuaki Matsubara, MD, PhD (+81-52-759-2111, matt@dpc.aichi-gakuin.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke (time frame: one year). 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 18 Jul 2012.