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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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01706783
Collaborator
(none)
35
Enrollment
4
Locations
2
Arms
13.2
Actual Duration (Months)
8.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
Actual Study Start Date :
Oct 12, 2012
Actual Primary Completion Date :
Nov 18, 2013
Actual Study Completion Date :
Nov 18, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: NNC0195-0092 (somapacitan)

Drug: 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
Other Names:
  • NNC0195-0092

    		•
    Active Comparator: Norditropin NordiFlex®

    Drug: 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

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (AEs) [From first administration of trial product and up until Day 49]

    Secondary Outcome Measures

    1. NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h) [From 0 to 168 hours]

    2. Norditropin NordiFlex® only: AUC (0-24h) [From 0 to 24 hours]

    3. NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h) [From 0 to 168 hours]

    4. Norditropin NordiFlex®, first dose administration only: AUC (0-24h) [From 0 to 24 hours]

    5. NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax) [From 0 to 168 hours]

    6. Norditropin NordiFlex®: Cmax [From 0 to 24 hours]

    7. Insulin-like growth factor I (IGF-I): AUC (0-168h) [From 0 to 168 hours]

    8. IGF-I: Cmax [From 0 to 168 hours]

    9. Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h) [From 0 to 168 hours]

    10. IGFBP-3: Cmax [From 0 to 168 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment of adults with GHD

    • Stable human growth hormone (hGH) replacement therapy for at least 3 months

    Exclusion Criteria:

    • Participation in another clinical trial within 3 months or receipt of any investigational medicinal product within 3 months prior to randomisation

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site København Ø Denmark 2100
    2 Novo Nordisk Investigational Site Odense Denmark 5000
    3 Novo Nordisk Investigational Site Århus C Denmark 8000
    4 Novo Nordisk Investigational Site Stockholm Sweden 141 86

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Global Clinical Registry (GCR,1452), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT01706783
    Other Study ID Numbers:
    • NN8640-3947
    • 2011-005484-24
    • U1111-1125-7331
    First Posted:
    Oct 15, 2012
    Last Update Posted:
    Dec 24, 2020
    Last Verified:
    Dec 1, 2020
    Additional relevant MeSH terms:
    Dwarfism, Pituitary
    Endocrine System Diseases

    Study Results

    No Results Posted as of Dec 24, 2020