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

Novo Nordisk A/S112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency

Interventions

somatropinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Percent change in truncal fat (kg)

Time frame: from the baseline to the end of treatment

Secondary Outcomes

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

Data from ClinicalTrials.gov

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