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

August 24, 2010 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Many Locations, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic diabetic patients not treated with acarbose for at least 3 months.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Acarbose (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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 20, 2010

First Posted (Estimate)

July 22, 2010

Study Record Updates

Last Update Posted (Estimate)

August 25, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13066
  • GB0710PL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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