E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects suffer from the metabolic syndrome. Effects of study medication on insulin resistance and vascular function will be studied respectively. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022489 |
E.1.2 | Term | Insulin resistance |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052066 |
E.1.2 | Term | Metabolic syndrome |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048554 |
E.1.2 | Term | Endothelial dysfunction |
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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 |
Our main objective is to determine the effect of HO-1 induction by heme arginate infusion on insulin resistance related to MetS. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to determine the effect on endothelial dysfunction, adipose tissue, markers for oxidative stress and vascular inflammation and indicators of HO activity. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At least 18 and not older than 70 years of age on the day of the first dosing. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. Metabolic syndrome defined by at least three out of five criteria: Elevated waist circumference (women ≥ 88, men ≥ 102 cm). Elevated triglycerides or drug treatment (≥ 1.7 mmol/L). Reduced HDL-cholesterol or drug treatment (women < 1.3 mmol/L, men < 1.0 mmol/L). Elevated blood pressure (systolic ≥ 130 mm Hg and/or diastolic ≥ 85 mm Hg) Elevated fasting glucose (≥ 6.1 mmol/L)
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E.4 | Principal exclusion criteria |
Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. History of smoking within the past year. History of or current abuse of drugs, alcohol or solvents. Known diabetes mellitus Fasting plasma glucose > 7.0 mmol/L or HbA1c > 6.2% Pregnancy or breast feeding (contraception for at least 3 months before inclusion is required for fertile women) Current use of antihypertensive, cardiac or other vasoactive medication Current use of acetylsalicylic acid Use of antioxidant vitamin supplements Inability to suspend the use of statins during trial participation Clinical evidence of cardiac or pulmonary disease Laboratory evidence of renal or hepatic abnormalities, defined as results exceeding twice the upper limit of normal range. Inability to understand the nature and extent of the trial and the procedures required. Participation in a drug trial within 60 days prior to the first dose. Febrile illness within 3 days before the first dose. Unconjugated hyperbilirubinemia (total bilirubin level > 10 μmol/L and a normal direct bilirubin level) suggesting the Gilbert Syndrome.
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E.5 End points |
E.5.1 | Primary end point(s) |
Insulin sensitivity derived from the glucose infusion rate measured by euglycemic hyperinsulinemic clamps following treatment with Normosang and arginine. |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
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 | No |
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 undergoing the trial. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |