E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
first-degree relatives of individuals with type 2 diabetes. |
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E.1.1.1 | Medical condition in easily understood language |
Diabetes is a common condition and in the majority it is due to insulin resistance. The current work investigates the role of melatonin on insulin resistance and glucose metabolism. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
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 |
The principal research question to be investigated by this study is: Does evening melatonin treatment have beneficial effects on measures of blood sugar (glucose) regulation. |
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E.2.2 | Secondary objectives of the trial |
The secondary research questions to be investigated in this study are: (1) Does evening melatonin treatment have beneficial effects on markers of cardiometabolic risk factors (blood fats, blood markers of inflammation and blood clotting [thrombosis] and blood pressure) 2)Does evening melatonin treatment have beneficial effects on markers of obesity (body weight, body mass index [BMI], waist circumference) 3)Does evening melatonin treatment have beneficial effects on genetic markers of circadian rhythm patterns in white blood cells 4)does evening melatonin change an individual's perception of their quality of sleep and daily sleeping/waking patterns
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Ability to understand and personally sign and date the informed consent form. • Male and female subjects above the age of 18; • At least one first degree relative with a confirmed diagnosis of type 2 diabetes • No personal history of type 2 diabetes • Absence of clinical symptoms and signs of infection • Absence of systemic disease which may interfere with glucose metabolism.
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E.4 | Principal exclusion criteria |
• subjects with diabetes on OGTT criteria at baseline will be excluded from study and referred to their primary care physician for advice • Pregnancy or breast feeding; • Illness that makes the subject unlikely to fully complete the study • Evidence of relevant renal insufficiency as indicated by an estimated glomerular filtration rate below 50 ml/min/m2. • Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as ALT, AST, GGT, alkaline phosphatase, or serum bilirubin (2.5 fold above upper limit of reference range). • Known or suspected intolerance or hypersensitivity to the study medication, closely related compounds, or any of the stated ingredients. • Use of melatonin, fluvoxamine, cimetidine, quinolones, carbamazepine, rifampicine, 5-methoxypsoralene or 8-methoxypsoralene within 4 weeks prior to the inclusion into the study. • Clinical symptoms and signs of infection • Subjects who consume more than 750mg caffeine/day (7 regular cups)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the proposed research will be differences in indices of glucose regulation (HbA1c, OGTT, insulin AUC) between intervention and control groups.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Five time points over 12 months period (3 monthly evaluation) but only 2 time points while on active therapy with IMP. |
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E.5.2 | Secondary end point(s) |
Measures of vascular inflammatory and thrombotic markers. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
The role of manipulating the circadian rhythm in improving glucose metabolism |
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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 | Yes |
E.8.1.4 | Double blind | No |
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.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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End of sample processing - it is anticipated this will be approximately 6 months after LPLV |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 1 |