E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male Type 2 diabetics with symptomatic testosterone deficiency and confirmed low levels of serum testosterone |
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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 Objectives
To study the efficacy of 1000mg of Nebido, compared with placebo administered as per the product licence on standard diabetes parameters in a UK primary care type 2 diabetes population and symptomatic testosterone deficiency syndrome (TDS).
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E.2.2 | Secondary objectives of the trial |
Secondary objectives To evaluate the efficacy of 1000mg of Nebido administered as per the product licence on sexual function, depression, and well-being in a UK primary care type 2 diabetic population and symptomatic testosterone deficiency syndrome (TDS.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Inclusion Criteria
1. Men over 18 with type 2 diabetes previously identified with a morning total testosterone of 12nmol/L or less or calculated free testosterone of 250 pmol/L or less. In line with ISSM criteria enyty citeria will be calculated from the mean of 2 measurements, at screening and baseline. 2. Symptoms of hypogonadism as defined by the clinician 3. Patients giving written informed consent. 4. Medication for erectile dysfunction at screening is allowed, but the pattern of use should be maintained. Commencement of PDE5 inhibitor, intracavernosal injection, intra-urethral alprostadil or vacuum device would necessitate withdrawal.
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E.4 | Principal exclusion criteria |
Exclusion Criteria
1. Any form of testosterone or oestrogen therapy. 2. Any contraindication to use of NEBIDO. 3. Patients taking anticoagulants. e.g warfarin 4. Patients taking anticonvulsants. 5. Current or past history of prostate cancer. 6. Clinically significantly raised PSA at baseline in the opinion of the investigator. 7 Patients with medical or psychological issues that, in the view of the physician, would warrant exclusio
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy measures
Changes in HbA1c from baseline.
• Secondary efficacy measures Lipid Profile LDL cholesterol, triglycerides, Waist circumference, BMI. Blood pressure HOMA – A standardized measure of insulin resistance. IIEF (International Index of Erectile Function) HADS ( Hospital Anxiety and Depression Scale) . AMSS (Ageing Male Symptom Score)
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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 | 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 | Information not present in EudraCT |
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.8.3 |
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 | Information not present in EudraCT |
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 | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |