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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Acarbose (Glucobay, BAYG5421)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Acarbose (Glucobay, BAYG5421)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile |  | approximately 6 months after acarbose treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Acarbose