Effects of Acarbose on Endothelial Function After a Mixed Meal in Newly Diagnosed Type 2 Diabetes

Technische Universität Dresden

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: acarbose; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00551954

AIDA a4

Details and patient eligibility

About

Endothelial dysfunction (ED) has been suggested as a possible causal link between postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. Recent trials demonstrated a reduction of cardiovascular events by treatment with the alpha glucosidase inhibitor acarbose - a drug which mainly reduces postprandial glucose excursions. We were interested whether patients with newly diagnosed type 2 diabetes showed postprandial ED and if so whether acarbose was able to improve this condition.

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 35-75 years
• type 2 diabetes (newly diagnosed)
• well glycemic control (HbA1c </= 8.1)
• leucocyte count > 6.2 or hs CrP > 1

Exclusion criteria

• hs CrP > 10
• type 1 diabetes
• previous treatment with antidiabetic drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

20 weeks of treatment with acarbose (100 mg t.i.d.)

Treatment:

Drug: acarbose

2

Placebo Comparator group

Description:

20 weeks of treatment with placebo (one tablet t.i.d.)

Treatment:

Drug: placebo