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

Diabetes Mellitus Clinical Trial

— ABDOMEN  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167231
• Other study ID #: 13066
• Secondary ID: GB0710PL
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: August 24, 2010
• Start date: May 2007
• Est. completion date: June 2008

Study information

• Verified date: August 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3310
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure		approximately 6 months after acarbose treatment initiation	No
Secondary	Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile		approximately 6 months after acarbose treatment initiation	Yes

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