Long-Term Trial on Growth Hormone Deficiency in Adults (GHDA)

Condition(s) targeted: Growth Hormone Deficiency (GHD)

Intervention: somatropin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Yoshihisa Ogawa, Study Director, Affiliation: Novo Nordisk Pharma Ltd.

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.

Official title: Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone Deficiency

Study design: Interventional, Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percent change in truncal fat (kg)

Secondary outcome:

Adverse events

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)

FPG, insulin, and HbA1C

IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio

Clinical laboratory tests

Minimum age: 18 Years. Maximum age: 66 Years. Gender(s): Both.

Criteria:

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

Kobe city, Japan

Clinical Trials at Novo Nordisk

Starting date: December 2003
Last updated: September 10, 2007