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Clinical Trials/NCT00519558
NCT00519558CompletedPhase 3

Investigation of the Efficacy and Safety of NN-220 for 24 Weeks in Adults With Growth Hormone Deficiency

Novo Nordisk A/S1 site in 1 country121 target enrollmentStarted: May 31, 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
121
Locations
1
Primary Endpoint
Percent change in truncal fat (kg) from baseline
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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
  • FPG, insulin, and HbA1c
  • 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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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