Growth Hormone Deficiency in Adults (GHDA)
Phase 3
Completed
- Conditions
- Growth Hormone DisorderAdult Growth Hormone Deficiency
- Registration Number
- NCT00519558
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Japan. The aim of this trial is to demonstrate superiority of the effect of NN-220 compared with that of placebo as assessed by the change in percent in truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with Growth Hormone Deficiency in Adults (GHDA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
Inclusion Criteria
- Subjects with diagnosed GHD
- If the subject has a history of treatment of treatment for a tumour of pituitary or peripheral site, two years or more must have 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent change in truncal fat (kg) from baseline at 24 weeks (end of treatment)
- Secondary Outcome Measures
Name Time Method FPG, insulin, and HbA1c Change in total body fat, total LBM, etc. from baseline to 24 weeks Clinical laboratory tests Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio Adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan