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A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

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ClinicalTrials.gov Identifier: NCT03075644
Recruitment Status : Completed
First Posted : March 9, 2017
Results First Posted : October 6, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.

Condition or disease Intervention/treatment Phase
Growth Hormone Disorder Adult Growth Hormone Deficiency Drug: somapacitan Drug: Norditropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018


Arm Intervention/treatment
Experimental: Somapacitan Drug: somapacitan
Once weekly subcutaneous injections (s.c., under the skin)

Active Comparator: Norditropin Drug: Norditropin
Daily subcutaneous injections (s.c., under the skin)




Primary Outcome Measures :
  1. Incidence of Adverse Events, Including Injection Site Reactions [ Time Frame: Weeks 0-53 ]
    An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which did not necessarily have a causal relationship with the treatment. Rate of AEs per 100 patient years at risk with onset after the first administration of trial product and up until end of the trial (53 weeks) or 14 days after last trial drug administration, whichever came first, are presented.


Secondary Outcome Measures :
  1. Change in Cross-sectional Total Adipose Tissue Compartments [ Time Frame: Week 0, week 52 ]
    Cross-sectional total adipose tissue compartments (TAT) were determined by quantitative computed tomography (CT) scans. Change from baseline (week 0) to end of treatment period (52 weeks) in cross-sectional TAT compartments is presented.

  2. Change in Subcutaneous Adipose Tissue Compartments [ Time Frame: Week 0, week 52 ]
    Subcutaneous adipose tissue compartments (SAT) was determined by quantitative CT scans. Change from baseline (week 0) to end of treatment period (52 weeks) in SAT compartments is presented.

  3. Change in Intra-abdominal or Visceral Adipose Tissue Compartments [ Time Frame: Week 0, week 52 ]
    Intra-abdominal or visceral adipose tissue (VAT) compartments was determined by quantitative CT scans. Change from baseline (week 0) to end of treatment period (52 weeks) in VAT compartments is presented.

  4. Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores [ Time Frame: Week 0, week 52 ]
    The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effectiveness of the medication, convenience and global satisfaction of treatment. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100. Change in TSQM-9 scores from baseline (week 0) to week 52 are presented.

  5. Change in Physical Examination [ Time Frame: Week 0, week 52 ]
    Physical examination parameters were evaluated for head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system, gastrointestinal system, incl. mouth; musculoskeletal system; nervous system (central and peripheral); skin; and lymph node palpation. The investigator evaluated the findings from the physical examination and classifies them as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Results are presented for week 0 and week 52.

  6. Change in Body Weight [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in body weight at week 52 is presented.

  7. Change in SBP and DBP [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 52 is presented.

  8. Change in Pulse [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in pulse at week 52 is presented.

  9. Change in ECG [ Time Frame: Week -3, week 52 ]
    The ECG was assessed by the investigator at baseline (week -3) and week 52 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at week -3 and week 52 are presented.

  10. Change in Haematology: Haemoglobin [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in haemoglobin at week 52 is presented.

  11. Change in Haematology: Haematocrit [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in haematocrit at week 52 is presented.

  12. Change in Haematology: Thrombocytes, Leucocytes [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in thrombocytes and leucocytes at week 52 is presented.

  13. Change in Haematology: Erythrocytes [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in erythrocytes at week 52 is presented.

  14. Change in Haematology: Mean Corpuscular Volume [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in mean corpuscular volume at week 52 is presented.

  15. Change in Haematology: Mean Corpuscular Haemoglobin Concentration [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented.

  16. Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in creatinine, uric acid, and bilirubin (total) at week 52 is presented.

  17. Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in creatinine kinase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) at week 52 is presented.

  18. Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in urea, sodium, potassium, chloride, phosphate (inorganic), calcium (total) (mmol/L) at week 52 is presented.

  19. Change in Biochemistry: Total Protein and Albumin [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in total protein and albumin at week 52 is presented.

  20. Change in Biochemistry: eGFR Creatinine [ Time Frame: Week -3, week 52 ]
    Estimated glomerular filtration rate (eGFR) creatinine (measured in milliliters per minute per 1.73 square meters [mL/min/1.73m^2]) was evaluated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change from baseline (week -3) in eGFR at week 52 is presented.

  21. Change in HbA1c [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in glycosylated haemoglobin (HbA1c) at week 52 is presented.

  22. Change in FPG [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in fasting plasma glucose (FPG) (mmol/L) at week 52 is presented.

  23. Change in Fasting Insulin [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in fasting insulin at week 52 is presented.

  24. Change in Steady State Beta Cell Function [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in steady state beta cell function (%B) at week 52 is presented.

  25. Change in Insulin Resistance [ Time Frame: Week -3, week 52 ]
    Change from baseline (week -3) in insulin resistance (IR) (Homeostatic model assessment (HOMA) estimates) at week 52 is presented.

  26. Occurrence of Anti-somapacitan Antibodies [ Time Frame: Weeks 0 - 53 ]
    Number of participants with anti-somapacitan antibodies at baseline (week 0) and week 53 are presented. This outcome measure is applicable only for the treatment arm "Somapacitan".

  27. Occurrence of Anti-hGH Antibodies [ Time Frame: Weeks 0 - 53 ]
    Number of participants with anti-human growth hormone (hGH) antibodies at baseline (week 0) and week 53 are presented.

  28. Incidence of Clinical Technical Complaints [ Time Frame: Weeks 0 - 53 ]
    A technical complaint was any written, electronic, or oral communication that alleged product (medicine or device) defects. Number of partipants who reported technical complaints during the course of the trial are presented.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - GHD diagnosed for at least 6 months (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive months (defined as 180 days) at screening - If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision 2/ Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's medical records - For subjects with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075644


Locations
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Japan
Novo Nordisk Investigational Site
Bunkyo-ku, Tokyo, Japan, 113-8603
Novo Nordisk Investigational Site
Chiba-shi, Chiba, Japan, 260-8677
Novo Nordisk Investigational Site
Fukuoka, Japan, 818 8502
Novo Nordisk Investigational Site
Kagoshima, Japan, 890-8520
Novo Nordisk Investigational Site
Kobe, Hyogo, Japan, 650-0017
Novo Nordisk Investigational Site
Kyoto-shi Kyoto, Japan, 612-8555
Novo Nordisk Investigational Site
Okayama, Okayama, Japan, 700-8558
Novo Nordisk Investigational Site
Osaka, Japan, 565-0871
Novo Nordisk Investigational Site
Sagamihara-shi, Kanagawa, Japan, 252-0375
Novo Nordisk Investigational Site
Tokyo, Japan, 134-0088
Novo Nordisk Investigational Site
Yamagata-shi, Yamagata, Japan, 990-9585
Novo Nordisk Investigational Site
Yokohama, Kanagawa, Japan, 222-0036
Sponsors and Collaborators
Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03075644    
Other Study ID Numbers: NN8640-4244
U1111-1181-1618 ( Other Identifier: World Health Organization (WHO) )
JapicCTI-173534 ( Registry Identifier: JAPIC )
First Posted: March 9, 2017    Key Record Dates
Results First Posted: October 6, 2020
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases