Back to resultsImpact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)
Primary Purpose
Diabetes Mellitus, Impaired Glucose Tolerance, Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
acarbose
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring acarbose, diabetes mellitus, impaired glucose tolerance, coronary artery disease
Eligibility Criteria
Inclusion Criteria:
- Patients who have been diagnosed with coronary artery disease, with type 2 diabetes or impaired glucose tolerance
Exclusion Criteria:
- 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
Sites / Locations
- Dept. of Intern. Med., School of Dentistry, Aichi Gakuin UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Acarbose
Arm Description
Outcomes
Primary Outcome Measures
sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00858676
Brief Title
Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)
Official Title
Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aichi Gakuin University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Impaired Glucose Tolerance, Coronary Artery Disease
Keywords
acarbose, diabetes mellitus, impaired glucose tolerance, coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acarbose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
acarbose
Other Intervention Name(s)
Glucobay
Intervention Description
50mg acarbose 3 times a day PO. duration: one year
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have been diagnosed with coronary artery disease, with type 2 diabetes or impaired glucose tolerance
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatsuaki Matsubara, MD, PhD
Phone
+81-52-759-2111
Email
matt@dpc.aichi-gakuin.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatsuaki Matsubara, MD, PhD
Organizational Affiliation
Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
City
Nagoya
ZIP/Postal Code
464-8650
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatsuaki Matsubara, MD, PhD
Phone
+81-52-759-2111
First Name & Middle Initial & Last Name & Degree
Tatsuaki Matsubara, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)
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