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

Aichi Gakuin University

Status and phase: Unknown; Phase 4

Conditions: Impaired Glucose Tolerance; Coronary Artery Disease; Diabetes Mellitus

Treatments: Drug: acarbose

Study type: Interventional

Funder types: Other

Identifiers

NCT00858676

AGU-75

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Acarbose

Active Comparator group

Treatment:

Drug: acarbose