E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Insulin-induced increased heart rate, blood pressure and cardiac output |
Insulin induceret stigning i puls, blodtryk og minutvolumen |
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E.1.1.1 | Medical condition in easily understood language |
Changes in heart rate, blood pressure, and cardiac function caused by insulin. |
Insulins ændringer i puls, blodtryk og hjertes pumpefunktion |
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E.1.1.2 | Therapeutic area | Diseases [C] - Injuries, poisonings, and occupational diseases [C21] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035785 |
E.1.2 | Term | Poisoning by agents primarily affecting the cardiovascular system |
E.1.2 | System Organ Class | 100000004863 |
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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 |
To observe the clinical effects of insulin, compared to placebo, on hemodynamic parameters (blood pressure, heart rate and cardiac output) in states of normal and beta-blocker-induced heart rate and blood pressure suppression in healthy volunteers |
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E.2.2 | Secondary objectives of the trial |
To observe the effects of Insulin on clinical and biochemical measures of resting energy expenditure and metabolism (ie free fatty acids) on days with insulin compared to days with placebo. Furthermore, adverse reactions associated with insulin/placebo administration are recorded. Gastric emptying time on days with insulin compared to placebo |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Eligible participants are males 18 to 39 years of age determined to be healthy by physical examination, medical history and routine laboratory tests (blood and urine) (normal levels of sodium, potassium, calcium, liver function, kidney function, hematological parameters, albumin, HbA1c, lipid levels). |
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E.4 | Principal exclusion criteria |
•Previous or existing metabolic disease Routine laboratory tests outside normal ranges • Any heart disease • Hypertension • Second and third degree atrioventricular conduction block XML File Identifier: sfGLcI6N1h13DS3BCrgS2oy47jU= Page 10/19 • Resting Systolic blood pressure >140 or <100 mmHg • Resting heart rate > 45 beats per minute (bpm) • Sick sinus syndrome • Pheochromocytoma • Asthma • Chronic obstructive pulmonary disease • Abnormal body mass index • Claudicatio intermittens • Raynaud syndrome • Diabetes • Latex allergy • Any contraindications to beta-blockers |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in cardiac output from baseline compared between study days |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline (T=0) to T+240 minutes. |
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E.5.2 | Secondary end point(s) |
1: Change in blood pressure (systolic, diastolic and mean arterial pressure in mmHg) and heart rate from baseline compared between study days 2: Effects of Insulin on stroke volume, heart rate and blood pressure parameters compared to days with placebo. 3: Percent change in plasma levels biochemical measurements (cholesterol, low density lipoprotein, high-density lipoprotein, glucose, sodium, potassium) 4: Peak plasma concentration (Cmax), time to peak plasma concentration (Tmax) and area under the plasma concentration versus time curve (AUC) of paracetamol on days with co-administration of insulin compared to days with placebo (saline).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: From baseline (T=0) to T+240 minutes. 2: T-15, T 0, T 5, T 15, T 30, T 45, T 60, T 90, T 120, T180, T240 3: Baseline, +30, +60, +90,+120, +240 minutes. 4: Baseline (T=0), +15, +30, +45, +60, +120, +240, +255,+270,+300 minutes.
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | No |
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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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 | |
E.8.9.1 | In the Member State concerned days | |