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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01167231
First received: July 16, 2010
Last updated: August 24, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Drug: Acarbose (Glucobay, BAYG5421)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:

Drug Information available for: Acarbose
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure [ Time Frame: approximately 6 months after acarbose treatment initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile [ Time Frame: approximately 6 months after acarbose treatment initiation ] [ Designated as safety issue: Yes ]

Enrollment: 3310
Study Start Date: May 2007
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167231

Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Sp. z o.o.
ClinicalTrials.gov Identifier: NCT01167231     History of Changes
Other Study ID Numbers: 13066, GB0710PL
Study First Received: July 16, 2010
Last Updated: August 24, 2010
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
Diabetes
Acarbose

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013