E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus Type 1 (DM-1) and hipogonadotrophic hypogonadism |
Diabetes Mellitus Tipo I e hipogonadismo hipogonadotropo |
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E.1.1.1 | Medical condition in easily understood language |
Diabetes Mellitus Type 1 (DM-1) and hipogonadotrophic hypogonadism |
Diabetes Mellitus Tipo I e hipogonadismo hipogonadotropo |
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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 |
Evaluate the effectiveness of testosterone replacement therapy in patients with DM1 and hypogonadotropic hypogonadism on insulin sensitivity, measured by eGDR (estimated Glucose Disposal Rate) and evaluate the effectiveness of testosterone replacement therapy in patients with DM1 and hypogonadotropic hypogonadism on the control anthropometric parameters glycemic blood pressure and lipid profile. |
Evaluar la eficacia del tratamiento sustitutivo con testosterona en pacientes con DM1 e hipogonadismo hipogonadotropo sobre la sensibilidad a la insulina, cuantificada mediante eGDR (estimated Glucose Disposal Rate) y evaluar la eficacia del tratamiento sustitutivo con testosterona en pacientes con DM1 e hipogonadismo hipogonadotropo sobre el control glicémico los parámetros antropométricos la presión arterial y el perfil lipídico. |
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E.2.2 | Secondary objectives of the trial |
Analyze changes in the international index of erectile dysfunction after 22 weeks of treatment with testosterone undecanoate in patients with DM1 and hypogonadotropic hypogonadism. |
Analizar los cambios en el índice internacional de disfunción eréctil tras 22 semanas de tratamiento con undecanoato de testosterona en pacientes con DM1 e hipogonadismo hipogonadotropo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men older than or equal to 18. 2. Submit a diagnosis of diabetes mellitus type 1 and hypogonadotropic hypogonadism, defined as: ? Levels of total testosterone <8nmol / L(2.3 ng/mL), or total testosterone levels between 8 and 12 nmol / L (2.3-3.5 ng/mL)and calculated free testosterone <225 pmol / L (65 pg / mL). ? Determination of LH below 8.6 mU / mL and / or FSH lower than 14.2 IU / L. 3. Being able to provide informed consent before randomization and agree to abide by the study protocol. |
1. Hombres con edad superior o igual a 18 años. 2. Presentar un diagnóstico de diabetes mellitus tipo 1 e hipogonadismo hipogonadotropo, definido como: ?Niveles de testosterona total < 8nmol/L(2.3 ng/mL), o niveles de testosterona total entre 8 y 12 nmol/L(2.3-3.5 ng/mL) y testosterona libre calculada < 225 pmol/L (65 pg/mL). ?Determinaciones de LH inferiores a 8,6 mU/mL y/o FSH inferiores a 14,2 UI/L. 3. Ser capaz de proporcionar un consentimiento informado antes de la aleatorización y estar de acuerdo en cumplir el protocolo de estudio |
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E.4 | Principal exclusion criteria |
1. Existence of chronic debilitating disease such as kidney failure, cirrhosis, HIV, COPD, heart failure, ischemic heart disease. 2. Patients with hypergonadotropic hypogonadism. 3. Patients diagnosed with panhypopituitarism. 4. Patients with hypogonadotropic hypogonadism secondary to pituitary tumor or empty sella. 5. Patients with hypogonadotropic hypogonadism secondary to hyperprolactinemia. 6. Patients with contraindications to the administration of testosterone: elevated PSA, breast carcinoma, prostate carcinoma, liver tumors 7. Patients previously treated with testosterona 8. Patients with allergy to testosterone and/or excipients. |
1. Existencia de enfermedad crónica debilitante como insuficiencia renal, cirrosis, HIV, EPOC, insuficiencia cardíaca, cardiopatía isquémica. 2. Pacientes con hipogonadismo hipergonadotropo. 3. Pacientes diagnosticados de panhipopituitarismo. 4. Pacientes con hipogonadismo hipogonadotropo secundario a tumor hipofisario o silla turca vacía. 5. Pacientes con hipogonadismo hipogonadotropo secundario a hiperprolactinemia. 6. Pacientes con contraindicaciones para la administración de testosterona: elevación PSA, carcinoma de glándula mamaria, carcinoma prostático, tumores hepáticos. 7. Pacientes previamente tratados con testosterona. 8. Pacientes con hipersensibilidad al principio activo o a alguno de los excipientes tal como indica la ficha técnica de undecanoato de testosterona. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changing values of eGDR after 6, 16 and 22 weeks of treatment with testosterone undecanoate / placebo. |
Cambio en los valores de eGDR tras 6, 16 y 22 semanas de tratamiento con undecanoato de testosterona/placebo. |
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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) |
Changes in glycemic control (HbA1c and FPG), anthropometric parameters (BMI, hip circumference, waist circumference), blood pressure and lipid profile. Score on the questionnaire of erectile dysfunction. |
Cambios en el control glicémico (HbA1c y glucosa plasmática en ayunas), parámetros antropométricos (IMC, perímetro cadera, perímetro cintura), presión arterial y perfil lipídico. Puntuación en el cuestionario de disfunción eréctil. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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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Last visit of the last subject undergoing the trial |
Ultima visita del último sujeto reclutado |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |