E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with angiographically verified coronary artery disease and newly detected type-2 diabetes. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Age 40-70 years • Angiographically verified coronary artery disease (> 50 % stenosis) • Diabetic oGTT at the occasion of angiography
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject recruited or upon decision of the principal investigator/sponsor in case of unability to recruit the planned number of subjects within a reasonable time frame of 2 years. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |