Status:
COMPLETED
Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Growth Hormone Disorder
Adult Growth Hormone Deficiency
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults
Eligibility Criteria
Inclusion
- GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
- Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
- GH replacement therapy for more than 3 months
- Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive
Exclusion
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Malignant disease
- Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
- Heart insufficiency, NYHA class greater than 2
- Subjects with diabetes with an HbA1C above 8.0%
- Diabetic receiving insulin treatment
- Stable pituitary replacement therapy for less than 3 months
- Impaired liver function
- Impaired kidney function
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00715689
Start Date
July 1 2008
End Date
March 1 2009
Last Update
February 8 2017
Active Locations (3)
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1
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
2
Novo Nordisk Investigational Site
København Ø, Denmark, 2100
3
Novo Nordisk Investigational Site
Odense, Denmark, 5000