Growth Hormone Deficiency in Adults (GHDA)

Phase 3CompletedNCT00519558

Novo Nordisk A/S121 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

121

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 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

Locations (1)

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Percent change in truncal fat (kg) from baseline

Time frame: at 24 weeks (end of treatment)

Secondary Outcomes

Change in total body fat, total LBM, etc. from baseline to 24 weeks

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

Clinical laboratory tests

FPG, insulin, and HbA1c

Data from ClinicalTrials.gov

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