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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:
ClinicalTrials.gov Identifier:
NCT01167231
First Posted: July 22, 2010
Last Update Posted: August 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
July 16, 2010
July 22, 2010
August 25, 2010
May 2007
March 2008   (Final data collection date for primary outcome measure)
Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure [ Time Frame: approximately 6 months after acarbose treatment initiation ]
Same as current
Complete list of historical versions of study NCT01167231 on ClinicalTrials.gov Archive Site
Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile [ Time Frame: approximately 6 months after acarbose treatment initiation ]
Same as current
Not Provided
Not Provided
 
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.
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Primary care clinic diabetic patients not treated with acarbose for at least 3 months.
Diabetes Mellitus
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
Group 1
Intervention: Drug: Acarbose (Glucobay, BAYG5421)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3310
June 2008
March 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT01167231
13066
GB0710PL
No
Not Provided
Not Provided
Medical Director, Bayer Sp. z o.o.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
August 2010