Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
NCT ID: NCT00715689
Last Updated: 2017-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2008-07-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
NNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
placebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
B
NNC126-0083
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
placebo
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
C
NNC126-0083
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
placebo
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
D
NNC126-0083
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
placebo
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Interventions
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NNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
NNC126-0083
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
NNC126-0083
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
NNC126-0083
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
placebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
placebo
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
placebo
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
placebo
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
20 Years
65 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Århus C, , Denmark
Novo Nordisk Investigational Site
København Ø, , Denmark
Novo Nordisk Investigational Site
Odense, , Denmark
Countries
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References
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Sondergaard E, Klose M, Hansen M, Hansen BS, Andersen M, Feldt-Rasmussen U, Laursen T, Rasmussen MH, Christiansen JS. Pegylated long-acting human growth hormone possesses a promising once-weekly treatment profile, and multiple dosing is well tolerated in adult patients with growth hormone deficiency. J Clin Endocrinol Metab. 2011 Mar;96(3):681-8. doi: 10.1210/jc.2010-1931. Epub 2010 Dec 22.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-001061-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN8630-1823
Identifier Type: -
Identifier Source: org_study_id
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