E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Growth hormone deficiency in adults |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Insulin sensitivity in GHD adults during GH replacement therapy with very low vs. standard GH dose. Insulin sensitivity is defined as a degree of insulin resistance- a state in which a given concentration of insulin produces a less-than-expected biological effect. |
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E.2.2 | Secondary objectives of the trial |
Bone mass and bone mineral mineral density in GHD adults during GH replacement therapy with very low vs. standard GH dose.
Tertiary endpoints: body composition, lipids, muscle strength and mobility, quality of life in GHD adults during GH replacement therapy with very low vs. standard GH dose. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 30 men, age 18-70 years, with known pituitary disease and adult onset of severe isolated GHD or multiple pituitary deficiencies and waist size ≥ 102 cm and/or BMI ≥ 28 kg/cm2
- 30 women, age 18-70 years, with known pituitary disease and adult onset of severe isolated GHD or multiple pituitary deficiencies and osteopenia, defined as a value of bone mineral density 1.0-2.5 SD below peak bone mass or T-score within -1.5 – 2.5 SD and osteoporosis, defined as a value of bone mineral density ≥ 2.5 SD below peak bone mass or T-score > -2.5 SD in lumbar spine, hip or total body using DEXA bone densitometry - premenopausal women should have negative results of pregnancy test at the time of inclusion - premenopausal women should agree to use double contraception during the study by means of p-pills and barrier anticonceptives like condoms, intrauterine spirals etc.
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E.4 | Principal exclusion criteria |
- diabetes mellitus - macro-albuminuria and /or serum creatinine ≥ 150 mmol/l - known ischemic heart disease - Alzheimer’s disease - Prader-Willy syndrome - active or cured malignancy - systemic disease - cured Cushing disease - cured acromegaly - pregnancy - lactation - ongoing long-term (more than 5 days) treatment with glucocorticoids or known intermittent need to be treated by glucocorticoids orally or by inhalation for more than 5 days - acute critical illness and complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions- sleep apnoea -unidentified treatment resistent respiratory infection -severe obesity (those patients exceeding a weight/height of 200%) - reluctance to be randomized
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E.5 End points |
E.5.1 | Primary end point(s) |
the rate of fall of blood glucose in percent per minute at iv insulin tolerance test, the measure of periferal insulin sensitivity in vivo, will be calculated using the following equation: K (glucose) = 0. 693 X 100/t1/2 (t1/2 is the time necessary for the glucose concentration to fall by one-half). Normally, the constant elimination is ≥ 1.1%. In diabetes patients it is always <1%. |
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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 | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | 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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18 months treatment is fully performed or a patient presented with serious AE before the last visit |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |