Prevention of Postprandial Hyperglycemia by Acarbose May be a Promising Therapeutic Strategy for Reducing the Increased Risk for Cardiovascular Disease

Acarbose in Cardiovascular Risk Management. Assessment of Clinical Efficacy and Safety of Acarbose and Its Effect on Selected Cardiovascular Risk Factors in Type 2 Diabetes Patients.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01167231

Acronym

ABDOMEN

Enrollment

3310

Registered

2010-07-22

Start date

2007-05-31

Completion date

2008-06-30

Last updated

2010-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes, Acarbose

Brief summary

The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. Additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. Further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.

Interventions

DRUGAcarbose (Glucobay, BAYG5421)

Patients treated with acarbose tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diabetes Mellitus * Age \>/= 18 years * Naive to acarbose (minimum 3 months before inclusion)

Exclusion criteria

* Hypersensitivity to acarbose or any of the excipients * Age \<18 years * Pregnancy and in nursing * Inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction * Chronic intestinal diseases associated with marked disorders of digestion or absorption * States which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld's syndrome \[an angina pectoris-like syndrome or aggravation of an angina pectoris due to the postprandial filling of the stomach\] and larger hernias) * Hepatic and severe renal impairment (creatinine clearance \<25 mL/min/ 1,73m2)

Design outcomes

Primary

Measure	Time frame
Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure	approximately 6 months after acarbose treatment initiation

Secondary

Measure	Time frame
Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile	approximately 6 months after acarbose treatment initiation

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026