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Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00858676
Recruitment Status : Unknown
Verified July 2012 by Tatsuaki Matsubara, MD, PhD, Aichi Gakuin University.
Recruitment status was:  Recruiting
First Posted : March 10, 2009
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
Tatsuaki Matsubara, MD, PhD, Aichi Gakuin University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Impaired Glucose Tolerance Coronary Artery Disease Drug: acarbose Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation
Study Start Date : April 2009
Actual Primary Completion Date : March 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose

Arm Intervention/treatment
Active Comparator: Acarbose Drug: acarbose
50mg acarbose 3 times a day PO. duration: one year
Other Name: Glucobay

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00858676

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Contact: Tatsuaki Matsubara, MD, PhD +81-52-759-2111

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Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University Recruiting
Nagoya, Japan, 464-8650
Contact: Tatsuaki Matsubara, MD, PhD    +81-52-759-2111      
Principal Investigator: Tatsuaki Matsubara, MD, PhD         
Sponsors and Collaborators
Aichi Gakuin University
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Principal Investigator: Tatsuaki Matsubara, MD, PhD Department of Internal Medicine, School of Dentistry, Aichi Gakuin University

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Responsible Party: Tatsuaki Matsubara, MD, PhD, professor, Aichi Gakuin University Identifier: NCT00858676     History of Changes
Other Study ID Numbers: AGU-75
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012
Keywords provided by Tatsuaki Matsubara, MD, PhD, Aichi Gakuin University:
diabetes mellitus
impaired glucose tolerance
coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs