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
- Conditions
- Growth Hormone DisorderAdult Growth Hormone Deficiency
- Interventions
- Registration Number
- NCT03075644
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Somapacitan somapacitan - Norditropin Norditropin -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events, Including Injection Site Reactions 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
Name Time Method Change in Cross-sectional Total Adipose Tissue Compartments 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.
Change in FPG Week -3, week 52 Change from baseline (week -3) in fasting plasma glucose (FPG) (mmol/L) at week 52 is presented.
Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores 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.
Change in Subcutaneous Adipose Tissue Compartments 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.
Change in SBP and DBP Week 0, week 52 Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 52 is presented.
Change in Pulse Week 0, week 52 Change from baseline (week 0) in pulse at week 52 is presented.
Change in Haematology: Mean Corpuscular Volume Week -3, week 52 Change from baseline (week -3) in mean corpuscular volume at week 52 is presented.
Change in Haematology: Mean Corpuscular Haemoglobin Concentration Week -3, week 52 Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented.
Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) Week -3, week 52 Change from baseline (week -3) in creatinine, uric acid, and bilirubin (total) at week 52 is presented.
Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT 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.
Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) 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.
Change in Fasting Insulin Week -3, week 52 Change from baseline (week -3) in fasting insulin at week 52 is presented.
Change in Steady State Beta Cell Function Week -3, week 52 Change from baseline (week -3) in steady state beta cell function (%B) at week 52 is presented.
Change in Intra-abdominal or Visceral Adipose Tissue Compartments 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.
Change in ECG 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.
Change in Physical Examination 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.
Change in Body Weight Week -3, week 52 Change from baseline (week -3) in body weight at week 52 is presented.
Change in Haematology: Haemoglobin Week -3, week 52 Change from baseline (week -3) in haemoglobin at week 52 is presented.
Change in Haematology: Haematocrit Week -3, week 52 Change from baseline (week -3) in haematocrit at week 52 is presented.
Change in Haematology: Thrombocytes, Leucocytes Week -3, week 52 Change from baseline (week -3) in thrombocytes and leucocytes at week 52 is presented.
Change in Haematology: Erythrocytes Week -3, week 52 Change from baseline (week -3) in erythrocytes at week 52 is presented.
Change in Biochemistry: eGFR Creatinine 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.
Change in HbA1c Week -3, week 52 Change from baseline (week -3) in glycosylated haemoglobin (HbA1c) at week 52 is presented.
Change in Insulin Resistance Week -3, week 52 Change from baseline (week -3) in insulin resistance (IR) (Homeostatic model assessment (HOMA) estimates) at week 52 is presented.
Occurrence of Anti-hGH Antibodies Weeks 0 - 53 Number of participants with anti-human growth hormone (hGH) antibodies at baseline (week 0) and week 53 are presented.
Incidence of Clinical Technical Complaints 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.
Change in Biochemistry: Total Protein and Albumin Week -3, week 52 Change from baseline (week -3) in total protein and albumin at week 52 is presented.
Occurrence of Anti-somapacitan Antibodies 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".
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Yokohama, Kanagawa, Japan