E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes mellitus (T2DM) is a common endocrine disorder caracterized by hyperinsulinaemia and insulin resistance. We aim to investigate if testosterone therapy can improve body composition, insulin sensitivity, lipid metabolism and quality of life in men with low to normal bioavailable testosterone levels (<7.3 nmol/l) and T2DM. |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes mellitus is a common hormonal disorder. We wish to establish if testosterone therapy can improve life in men with T2DM and low to normal testosterone. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10043368 |
E.1.2 | Term | Testosterone decreased |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012613 |
E.1.2 | Term | Diabetes mellitus non-insulin-dependent |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 investigate if treatment with testosterone in men with low to normal bioavailable testosterone levels (<7.3 nmol/l) and T2DM will increase lean body mass |
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E.2.2 | Secondary objectives of the trial |
To investigate if treatment with testosterone in men with low to normal bioavailable testosterone levels (<7.3 nmol/l) and T2DM will 1) increase insulinsensitivity 2) reduce lipide in the liver 3) increase adiponectin-level og decrease CRP-level. 4) improve quality of life and increase physical activity 5) increase number of satellitecells in muscles |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All participating patients have to give a spoken and written informed consent. 1) Man 50-70 years of age 2) Type 2 DM diagnosed within the last 10 years 3) Metformin treated type 2 DM >= 3 months 4) Bioavailable testosterone levels < 7.3 nmol/L |
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E.4 | Principal exclusion criteria |
HbA1c ≥ 9,0 %, BMI ≤ 40 kg/m2, Hæmatokrit > 50%, Known malignant disease, PSA > 3 ug/L, Nykturi > 3 times, Abnormal rutine blodsamples, Severe hypertension, Significant EKG-changes, Wish of parenthood, Active mental illness, present or former abuse within one year, Severe ilness of heart-, lung- or kidney, Primary or secondary hypogonadisme. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Insulin sensitivity (Euglycemic hyperinsulinaemic clamp)
Regional body composition and liver fat (DXA- and MR-scans and spect)
Glucose and lipid oxidation (Indirecet calorimetry)
Myostatin and satellite cells (Muscle biopsy)
Hormones: Adiponectin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.
Other blood samples: Lipids Muscle power (Power Rig)
Physical activity (Accelerometer)
Quality of life (Questionaires)
Sexual function (Questionaires)
Vessel stiffness (pulse wave velocity and intima-media thickness)
Safety parameters: PSA, Hb, hematocrit |
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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 | Yes |
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) | 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 | 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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 1 |