E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
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 |
Primary objective is the delta change in whole body insulin sensitivity expressed as glucose disposal rate (μmol/kg/min) upon 2 weeks of Na-PB vs. placebo treatment. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are muscle mitochondrial oxidative capacity (pmol/mg/s), muscle and liver fat content (%), leucine oxidation rate (μmol/kg/min) and energy metabolism (respiratory exchange ratio and kJ/kg/min). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Patients are able to provide signed and dated written informed consent prior to any study specific procedures 2. Women are post-menopausal (defined as at least 1 year post cessation of menses) and aged ≥ 45 and ≤ 70 years. Males are aged ≥ 40 years and ≤ 70 years 3. Patients should have suitable veins for cannulation or repeated venipuncture 4. Caucasians 5. BMI: 28-38 kg/m2 6. Diagnosed with T2D at least 1.5 years before the start of the study 7. Relatively well-controlled T2D: HbA1c < 8.5% 8. Oral glucose lowering medication: metformin only or in combination with sulfonylurea agents and/or on stable dose of a DPPIV inhibitor treatment for at least the last 3 months 9. No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy 10. No signs of active liver or kidney malfunction |
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator 2. Participate in physical activity more than 3 times a week 3. Unstable body weight (weight gain or loss > 5 kg in the last three months) 4. Insulin dependent T2D 5. Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema 6. Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids 7. Smoking 8. Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l
A medical doctor will judge participation eligibility based on the medical history questionnaire, medication use and fasting blood parameters. If the medical doctor advises that a patient cannot participate, the patient will be excluded from enrollment.
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E.5 End points |
E.5.1 | Primary end point(s) |
The endpoint of study is the measurement of insulin sensitivity of the 16th participant after the second intervention period. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after finalising the second intervention period |
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E.5.2 | Secondary end point(s) |
The second endpoints of study are the measurements of mitochondrial function, energy metabolism, leucine oxidation, muscle and liver fat of the 16th participant |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after the second intervention period. |
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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 | 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 |
IMP used as tool to evaluate the role of branched-chain amino acid (BCAA) metabolism in type 2 diabetes. With Pheburane stimulates BCAA oxidation, potentially improving metabolic health in patients with type 2 diabetes |
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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) | 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 | 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 | 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.8.5 | 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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |