Adult Growth Hormone Deficiency, Growth Hormone Disorder
Conditions
Brief summary
This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different treatment regiments.
Interventions
DRUGsomatropin
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who completed GHLiquid-1518. * If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded. * Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies.
Exclusion criteria
* Subject with a history of acromegaly. * Subject with diabetes mellitus. * Subject suffering from malignancy. * Several medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in truncal fat (kg) | from the baseline to the end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in Total body fat, Total LBM, etc. from the baseline to the end of treatment | — |
| Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) | — |
| Adverse events | — |
| IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio | — |
| Clinical laboratory tests | — |
| FPG, insulin, and HbA1C | — |
Countries
Japan
Outcome results
None listed