Effects of acarbose on endothelial function, platelet activity, insulin sensitivity and glucose control in subjects with coronary artery disease and new onset type-II diabetes.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004012-78-AT

Enrollment

Registered

2005-11-11

Start date

2005-12-16

Completion date

Unknown

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with angiographically verified coronary artery disease and newly detected type-2 diabetes.

Interventions

Trade Name: Glucobay Pharmaceutical Form: Tablet INN or Proposed INN: Acarbose Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the place

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age 40-70 years • Angiographically verified coronary artery disease (> 50 % stenosis) • Diabetic oGTT at the occasion of angiography Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Acute coronary syndrome or cerebrovascular event within the previous 8 weeks • Acetylsalicylic acid at a dose > 100 mg daily • Any other NSAID or antiplatelet drug • BMI > 35 kg/m2 • HbA1c > 7.5 % • Serum creatinine > 2.5 mg/dl • GOT/GPT > 3x upper limit of normal • Heart failure > class NYHA II • Uncontrolled hypertension (blood pressure > 165 / 100 mmHg) • New onset statin or ACE-inhibitor within the previous 8 weeks • Known intolerance of acarbose • Chronic inflammatory bowel disease • Malabsorption syndromes • any antidiabetic medication

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of 100 mg acarbose (t.i.d.) on endothelial function in subjects with coronary artery disease and newly diagnosed type-II diabetes.;Secondary Objective: To investigate the effect of 100 mg acarbose (t.i.d.) on platelet activity, insulin sensitivity and glucose control in subjects with coronary artery disease and newly diagnosed type-II diabetes.;Primary end point(s): Primary: • Flow-mediated dilation of the brachial artery (FMD) 2 hours after ingestion of saccharose. Secondary: • Flow-mediated dilation of the brachial artery (FMD) 3 hours after ingestion of saccharose. • Change of FMD from before to 2 & 3 hours after ingestion of saccharose • Nitroglycerine-mediated dilation of the brachial artery (NMD) in the fasting state and 2 hours after ingestion of saccharose • Proportion of subjects with an improvement of FMD of at least 2.5 % (absolute) • Insulin resistance estimated according to Stumvoll et al. (23). • b-cell function assessed from the saccharose-test 30 min change of glucose and insulin normalised for insulin resistance. • Area under the curve for glucose in the saccharose-test • Platelet activity as assessed by flow-cytometry • High sensitive CRP	—

Measure

Time frame

Main Objective: To investigate the effect of 100 mg acarbose (t.i.d.) on endothelial function in subjects with coronary artery disease and newly diagnosed type-II diabetes.;Secondary Objective: To investigate the effect of 100 mg acarbose (t.i.d.) on platelet activity, insulin sensitivity and glucose control in subjects with coronary artery disease and newly diagnosed type-II diabetes.;Primary end point(s): Primary: • Flow-mediated dilation of the brachial artery (FMD) 2 hours after ingestion of saccharose. Secondary: • Flow-mediated dilation of the brachial artery (FMD) 3 hours after ingestion of saccharose. • Change of FMD from before to 2 & 3 hours after ingestion of saccharose • Nitroglycerine-mediated dilation of the brachial artery (NMD) in the fasting state and 2 hours after ingestion of saccharose • Proportion of subjects with an improvement of FMD of at least 2.5 % (absolute) • Insulin resistance estimated according to Stumvoll et al. (23). • b-cell function assessed from the saccharose-test 30 min change of glucose and insulin normalised for insulin resistance. • Area under the curve for glucose in the saccharose-test • Platelet activity as assessed by flow-cytometry • High sensitive CRP

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026