E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
type 2 diabetes
testosteron < 11 nmol/L |
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E.1.1.1 | Medical condition in easily understood language |
male type 2 diabetes patients with low testosterone level |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
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:
To increase low free testosterone in men with T2D by vit D suppletion
Evaluation the effect of vitamin D supplementation on the free testosterone level in men with type 2 diabetes and low testosterone level.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives:
a. Influence of bone on glucose hemostasis by measuring osteocalcin and insulin resistance (Mathematical HOMA) , pre and post study period
b. Clinical effect on libido by validated questionnaires
c. Is the increased level of testosterone either dependent or independent of the osteocalcin variation
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key inclusion criteria
• Caucasian men
• age: 18 - 65 years
• BMI < 40 kg/m²
• type 2 diabetes mellitus
• HbA1c ≤ 64 mmol/mol, ( 8%)
• vitamin D < 50 nmol/L
• total testosterone < 11nmol/L.
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E.4 | Principal exclusion criteria |
Key exclusion criteria
• Chronic renal failure defined as eGFR less than 60 mL/min/1.73 m2 for three or more months
• Chronic liver failure GOT/GPT < 2N, total bilirubin < 2N and INR < 1.7
• Hypocalcaemia defined as calcium levels below lower limit of normal range < 2.10 mmol/L
• Hypomagnesaemia defined as magnesium < 0.65 mmol/L
• Hypoalbuminemia defined as albumin < 3 g/dL
• A history of orchidectomy
• The use of Testosterone supply
• The use of medications affecting bone turnover (cholecalciferol, vitamin K, bisphosphonate, anti-epileptic medication, corticosteroid use, heparin etc.
• Any supplementation containing vitamin D alone or in combination within 2 months before the screening visit and during the study
• BMI > 40 Kg/m²
• Neuroleptic treatment
Known bone disease (osteoporosis, Paget diseas, primary hyper parathyroid)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study will be the (change) in free testosterone concentration after 10 days and 3 months. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 10 days and 3 months. |
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E.5.2 | Secondary end point(s) |
Key secondary endpoints are: see above
• Changes from baseline to 10 days and 3 months in total osteocalcin concentration
• Proportion of participants with a low total testosterone level (<11 nmol/L) in the active treatment arm (vitamin D) compared to the placebo group one year after intervention.
• Mean change from baseline to 3 months in glucose concentration using A1c
• Clinical effect on libido by validated questionnaires
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 10 days and 3 months |
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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 | 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 | 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.8.2.4 | 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 | 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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 7 |