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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)

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Bayer

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Drug: Acarbose (Glucobay, BAYG5421)

Study type

Observational

Funder types

Industry

Identifiers

NCT01167231
GB0710PL
13066

Details and patient eligibility

About

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.

Enrollment

3,310 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

3,310 participants in 1 patient group

Group 1
Treatment:
Drug: Acarbose (Glucobay, BAYG5421)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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