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

NCT ID: NCT01167231

Last Updated: 2010-08-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3310 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-06-30

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.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Acarbose (Glucobay, BAYG5421)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Sp. z o.o.

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Many Locations, , Poland

Countries

Poland

Other Identifiers

GB0710PL

Identifier Type: -

Identifier Source: secondary_id

13066

Identifier Type: -

Identifier Source: org_study_id