A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
NCT ID: NCT01706783
Last Updated: 2020-12-24
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
PHASE1
35 participants
INTERVENTIONAL
2012-10-12
2013-11-18
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
NONE
Study Groups
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NNC0195-0092 (somapacitan)
somapacitan
Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 (somapacitan) in an escalating order
Norditropin NordiFlex®
Norditropin NordiFlex®
Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency
Interventions
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somapacitan
Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 (somapacitan) in an escalating order
Norditropin NordiFlex®
Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable human growth hormone (hGH) replacement therapy for at least 3 months
Exclusion Criteria
* Active malignant disease or malignant disease within the last 5 years with exception of fully treated local basal cell carcinoma or carcinoma in situ of cervix
* Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
* Heart insufficiency, New York Heart Association (NYHA) class above 2
* Adults with GHD with poorly controlled diabetes mellitus with a glycosylated haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment
* Stable pituitary replacement therapy for less than 3 months
20 Years
70 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
Novo Nordisk Investigational Site
Stockholm, , Sweden
Countries
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References
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Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.
Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.
Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.
Rasmussen MH, Janukonyte J, Klose M, Marina D, Tanvig M, Nielsen LF, Hoybye C, Andersen M, Feldt-Rasmussen U, Christiansen JS. Reversible Albumin-Binding GH Possesses a Potential Once-Weekly Treatment Profile in Adult Growth Hormone Deficiency. J Clin Endocrinol Metab. 2016 Mar;101(3):988-98. doi: 10.1210/jc.2015-1991. Epub 2016 Jan 4.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2011-005484-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1125-7331
Identifier Type: OTHER
Identifier Source: secondary_id
NN8640-3947
Identifier Type: -
Identifier Source: org_study_id