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

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Acarbose (Glucobay, BAYG5421)

• Registration Number: NCT01167231
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-03
• Study Completion: 2008-06
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-22
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-24
• Last Update Posted: 2010-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3310

Inclusion Criteria

• Diabetes Mellitus
• Age >/= 18 years
• Naive to acarbose (minimum 3 months before inclusion)

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Acarbose (Glucobay, BAYG5421)	-

Primary Outcome Measures

Name	Time	Method
Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure	approximately 6 months after acarbose treatment initiation

Secondary Outcome Measures

Name	Time	Method
Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile	approximately 6 months after acarbose treatment initiation