Adult Growth Hormone Deficiency, Growth Hormone Disorder
Conditions
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.
Interventions
DRUGsomapacitan
Once weekly subcutaneous injections (s.c., under the skin)
DRUGNorditropin
Daily subcutaneous injections (s.c., under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 Haematology: Mean Corpuscular Volume | Week -3, week 52 | Change from baseline (week -3) in mean corpuscular volume at week 52 is presented. |
| 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 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 Biochemistry: Total Protein and Albumin | Week -3, week 52 | Change from baseline (week -3) in total protein and albumin 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 FPG | Week -3, week 52 | Change from baseline (week -3) in fasting plasma glucose (FPG) (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 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-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. |
| 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 Haematology: Mean Corpuscular Haemoglobin Concentration | Week -3, week 52 | Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented. |
Countries
Japan
Participant flow
Recruitment details
The trial was conducted at 12 sites in Japan.
Pre-assignment details
Participants were randomised in a 3:1 manner to receive either somapacitan or Norditropin®.
Participants by arm
| Arm | Count |
|---|---|
| Norditropin® Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg). | 16 |
| Somapacitan Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg. | 46 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Somapacitan | Total | Norditropin® |
|---|---|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 12.1 | 52.8 years STANDARD_DEVIATION 12.1 | 49.3 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 62 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 46 Participants | 62 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 22 Participants | 29 Participants | 7 Participants |
| Sex: Female, Male Male | 24 Participants | 33 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 46 |
| other Total, other adverse events | 11 / 16 | 33 / 46 |
| serious Total, serious adverse events | 0 / 16 | 4 / 46 |
Outcome results
Primary
Incidence of Adverse Events, Including Injection Site Reactions
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.
Time frame: Weeks 0-53
Population: Safety analysis set (SAS) which comprised all randomised participants who received at least one dose of randomised treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Norditropin® | Incidence of Adverse Events, Including Injection Site Reactions | 309.8 Event rate per 100 patient years |
| Somapacitan | Incidence of Adverse Events, Including Injection Site Reactions | 312.7 Event rate per 100 patient years |
Secondary
Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT
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.
Time frame: Week -3, week 52
Population: SAS which comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Norditropin® | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | ALT | -4.9 Units per liter (U/L) | Standard Deviation 13.4 |
| Norditropin® | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | ALP | -9.1 Units per liter (U/L) | Standard Deviation 11 |
| Norditropin® | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | AST | -3.2 Units per liter (U/L) | Standard Deviation 10.3 |
| Norditropin® | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | GGT | -9.4 Units per liter (U/L) | Standard Deviation 19.2 |
| Norditropin® | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | Creatinine kinase | -10.4 Units per liter (U/L) | Standard Deviation 66.8 |
| Somapacitan | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | GGT | -0.6 Units per liter (U/L) | Standard Deviation 6.6 |
| Somapacitan | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | Creatinine kinase | 6.8 Units per liter (U/L) | Standard Deviation 261.3 |
| Somapacitan | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | ALT | -1.6 Units per liter (U/L) | Standard Deviation 9.4 |
| Somapacitan | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | AST | -1.4 Units per liter (U/L) | Standard Deviation 7.2 |
| Somapacitan | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | ALP | -0.7 Units per liter (U/L) | Standard Deviation 11.4 |
Secondary
Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total)
Change from baseline (week -3) in creatinine, uric acid, and bilirubin (total) at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Norditropin® | Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) | Creatinine | 1.4 Micromoles per liter (umol/L) | Standard Deviation 7.8 |
| Norditropin® | Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) | Uric acid | 25.9 Micromoles per liter (umol/L) | Standard Deviation 41.9 |
| Norditropin® | Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) | Total bilirubin | -0.21 Micromoles per liter (umol/L) | Standard Deviation 5.21 |
| Somapacitan | Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) | Creatinine | 1.0 Micromoles per liter (umol/L) | Standard Deviation 7.4 |
| Somapacitan | Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) | Uric acid | 6.7 Micromoles per liter (umol/L) | Standard Deviation 49.9 |
| Somapacitan | Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) | Total bilirubin | 0.56 Micromoles per liter (umol/L) | Standard Deviation 3.81 |
Secondary
Change in Biochemistry: eGFR Creatinine
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.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Biochemistry: eGFR Creatinine | -1.4 mL/min/1.73m^2 | Standard Deviation 7.1 |
| Somapacitan | Change in Biochemistry: eGFR Creatinine | -1.4 mL/min/1.73m^2 | Standard Deviation 6.2 |
Secondary
Change in Biochemistry: Total Protein and Albumin
Change from baseline (week -3) in total protein and albumin at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS which comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Norditropin® | Change in Biochemistry: Total Protein and Albumin | Total protein | -0.6 Grams/liter (g/L) | Standard Deviation 3.7 |
| Norditropin® | Change in Biochemistry: Total Protein and Albumin | Albumin | 0.3 Grams/liter (g/L) | Standard Deviation 2.8 |
| Somapacitan | Change in Biochemistry: Total Protein and Albumin | Total protein | 1.4 Grams/liter (g/L) | Standard Deviation 3.1 |
| Somapacitan | Change in Biochemistry: Total Protein and Albumin | Albumin | 1.3 Grams/liter (g/L) | Standard Deviation 2.4 |
Secondary
Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total)
Change from baseline (week -3) in urea, sodium, potassium, chloride, phosphate (inorganic), calcium (total) (mmol/L) at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Norditropin® | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Urea | 0.29 mmol/L | Standard Deviation 0.83 |
| Norditropin® | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Sodium | -0.3 mmol/L | Standard Deviation 1.9 |
| Norditropin® | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Potassium | -0.04 mmol/L | Standard Deviation 0.29 |
| Norditropin® | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Chloride | 0.4 mmol/L | Standard Deviation 2.8 |
| Norditropin® | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Inorganic phosphate | 0.000 mmol/L | Standard Deviation 0.185 |
| Norditropin® | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Total calcium | -0.067 mmol/L | Standard Deviation 0.068 |
| Somapacitan | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Inorganic phosphate | 0.028 mmol/L | Standard Deviation 0.172 |
| Somapacitan | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Urea | 0.71 mmol/L | Standard Deviation 1.29 |
| Somapacitan | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Chloride | 0.6 mmol/L | Standard Deviation 2.9 |
| Somapacitan | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Sodium | 0.2 mmol/L | Standard Deviation 2.8 |
| Somapacitan | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Total calcium | -0.051 mmol/L | Standard Deviation 0.082 |
| Somapacitan | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Potassium | 0.04 mmol/L | Standard Deviation 0.34 |
Secondary
Change in Body Weight
Change from baseline (week -3) in body weight at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Body Weight | 0.66 Kilogram (Kg) | Standard Deviation 2.5 |
| Somapacitan | Change in Body Weight | -0.29 Kilogram (Kg) | Standard Deviation 3.49 |
Secondary
Change in Cross-sectional Total Adipose Tissue Compartments
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.
Time frame: Week 0, week 52
Population: FAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Cross-sectional Total Adipose Tissue Compartments | 7.450 Square centimeters (cm^2) | Standard Deviation 32.177 |
| Somapacitan | Change in Cross-sectional Total Adipose Tissue Compartments | -7.091 Square centimeters (cm^2) | Standard Deviation 58.893 |
Secondary
Change in ECG
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.
Time frame: Week -3, week 52
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of randomised treatment. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Norditropin® | Change in ECG | week -3 | Normal | 16 Participants |
| Norditropin® | Change in ECG | week -3 | Abnormal NCS | 0 Participants |
| Norditropin® | Change in ECG | week -3 | Abnormal CS | 0 Participants |
| Norditropin® | Change in ECG | week 52 | Normal | 15 Participants |
| Norditropin® | Change in ECG | week 52 | Abnormal NCS | 0 Participants |
| Norditropin® | Change in ECG | week 52 | Abnormal CS | 0 Participants |
| Somapacitan | Change in ECG | week 52 | Abnormal NCS | 8 Participants |
| Somapacitan | Change in ECG | week -3 | Normal | 39 Participants |
| Somapacitan | Change in ECG | week 52 | Normal | 37 Participants |
| Somapacitan | Change in ECG | week -3 | Abnormal NCS | 7 Participants |
| Somapacitan | Change in ECG | week 52 | Abnormal CS | 0 Participants |
| Somapacitan | Change in ECG | week -3 | Abnormal CS | 0 Participants |
Secondary
Change in Fasting Insulin
Change from baseline (week -3) in fasting insulin at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Fasting Insulin | -16.7 Picomoles per liter (pmol/L) | Standard Deviation 54.1 |
| Somapacitan | Change in Fasting Insulin | -8.7 Picomoles per liter (pmol/L) | Standard Deviation 44.7 |
Secondary
Change in FPG
Change from baseline (week -3) in fasting plasma glucose (FPG) (mmol/L) at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in FPG | 0.014 mmol/L | Standard Deviation 0.442 |
| Somapacitan | Change in FPG | 0.089 mmol/L | Standard Deviation 0.453 |
Secondary
Change in Haematology: Erythrocytes
Change from baseline (week -3) in erythrocytes at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Haematology: Erythrocytes | -0.086 cells per picoliter | Standard Deviation 0.271 |
| Somapacitan | Change in Haematology: Erythrocytes | -0.007 cells per picoliter | Standard Deviation 0.228 |
Secondary
Change in Haematology: Haematocrit
Change from baseline (week -3) in haematocrit at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Haematology: Haematocrit | -0.64 Percentage point of haematocrit | Standard Deviation 2.76 |
| Somapacitan | Change in Haematology: Haematocrit | 0.04 Percentage point of haematocrit | Standard Deviation 2.31 |
Secondary
Change in Haematology: Haemoglobin
Change from baseline (week -3) in haemoglobin at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Haematology: Haemoglobin | -2.071 Grams/liter (g/L) | Standard Deviation 7.79 |
| Somapacitan | Change in Haematology: Haemoglobin | 0.311 Grams/liter (g/L) | Standard Deviation 6.026 |
Secondary
Change in Haematology: Mean Corpuscular Haemoglobin Concentration
Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Haematology: Mean Corpuscular Haemoglobin Concentration | 0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.47 |
| Somapacitan | Change in Haematology: Mean Corpuscular Haemoglobin Concentration | 0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.45 |
Secondary
Change in Haematology: Mean Corpuscular Volume
Change from baseline (week -3) in mean corpuscular volume at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Haematology: Mean Corpuscular Volume | 0.00 Femtoliters (fL) | Standard Deviation 2.45 |
| Somapacitan | Change in Haematology: Mean Corpuscular Volume | 0.29 Femtoliters (fL) | Standard Deviation 1.91 |
Secondary
Change in Haematology: Thrombocytes, Leucocytes
Change from baseline (week -3) in thrombocytes and leucocytes at week 52 is presented.
Time frame: Week -3, week 52
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of randomised treatment. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Norditropin® | Change in Haematology: Thrombocytes, Leucocytes | Thrombocytes | 0.1 10^9 cells/L | Standard Deviation 27.7 |
| Norditropin® | Change in Haematology: Thrombocytes, Leucocytes | Leucocytes | -0.29 10^9 cells/L | Standard Deviation 1.01 |
| Somapacitan | Change in Haematology: Thrombocytes, Leucocytes | Thrombocytes | 5.7 10^9 cells/L | Standard Deviation 33.5 |
| Somapacitan | Change in Haematology: Thrombocytes, Leucocytes | Leucocytes | -0.50 10^9 cells/L | Standard Deviation 1.43 |
Secondary
Change in HbA1c
Change from baseline (week -3) in glycosylated haemoglobin (HbA1c) at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in HbA1c | -0.04 Percentage point of HbA1c | Standard Deviation 0.22 |
| Somapacitan | Change in HbA1c | -0.07 Percentage point of HbA1c | Standard Deviation 0.21 |
Secondary
Change in Insulin Resistance
Change from baseline (week -3) in insulin resistance (IR) (Homeostatic model assessment (HOMA) estimates) at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Insulin Resistance | -0.60 Percentage (%) of IR | Standard Deviation 2.03 |
| Somapacitan | Change in Insulin Resistance | -0.25 Percentage (%) of IR | Standard Deviation 1.7 |
Secondary
Change in Intra-abdominal or Visceral Adipose Tissue Compartments
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.
Time frame: Week 0, week 52
Population: FAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Intra-abdominal or Visceral Adipose Tissue Compartments | 0.671 cm^2 | Standard Deviation 15.284 |
| Somapacitan | Change in Intra-abdominal or Visceral Adipose Tissue Compartments | -2.618 cm^2 | Standard Deviation 29.123 |
Secondary
Change in Physical Examination
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.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of randomised treatment. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Norditropin® | Change in Physical Examination | Week 0: Cardiovascular system | Normal | 16 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Head, ears, eyes, nose, throat, neck | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Head, ears, eyes, nose, throat, neck | Abnormal CS | 1 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Head, ears, eyes, nose, throat, neck | Normal | 14 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Head, ears, eyes, nose, throat, neck | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Head, ears, eyes, nose, throat, neck | Abnormal CS | 1 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Respiratory system | Normal | 16 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Respiratory system | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Respiratory system | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Respiratory system | Normal | 15 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Respiratory system | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Respiratory system | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Head, ears, eyes, nose, throat, neck | Normal | 15 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Cardiovascular system | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Cardiovascular system | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Cardiovascular system | Normal | 15 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Cardiovascular system | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Cardiovascular system | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Gastrointestinal system | Normal | 15 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Gastrointestinal system | Abnormal NCS | 1 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Gastrointestinal system | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Gastrointestinal system | Normal | 15 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Gastrointestinal system | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Gastrointestinal system | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Musculoskeletal system | Normal | 16 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Musculoskeletal system | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Musculoskeletal system | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Musculoskeletal system | Normal | 15 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Musculoskeletal system | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Musculoskeletal system | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Nervous system | Normal | 16 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Nervous system | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Nervous system | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Nervous system | Normal | 15 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Nervous system | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Nervous system | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Skin | Normal | 16 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Skin | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Skin | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Skin | Normal | 15 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Skin | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Skin | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Lymph node palpation | Normal | 16 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Lymph node palpation | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 0: Lymph node palpation | Abnormal CS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Lymph node palpation | Normal | 15 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Lymph node palpation | Abnormal NCS | 0 Participants |
| Norditropin® | Change in Physical Examination | Week 52: Lymph node palpation | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Lymph node palpation | Abnormal NCS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Head, ears, eyes, nose, throat, neck | Normal | 45 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Musculoskeletal system | Normal | 45 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Head, ears, eyes, nose, throat, neck | Abnormal NCS | 1 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Skin | Normal | 46 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Head, ears, eyes, nose, throat, neck | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Musculoskeletal system | Abnormal NCS | 1 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Head, ears, eyes, nose, throat, neck | Normal | 43 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Lymph node palpation | Normal | 44 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Head, ears, eyes, nose, throat, neck | Abnormal NCS | 1 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Musculoskeletal system | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Head, ears, eyes, nose, throat, neck | Abnormal CS | 1 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Skin | Abnormal NCS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Respiratory system | Normal | 46 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Respiratory system | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Musculoskeletal system | Normal | 43 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Respiratory system | Abnormal NCS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Lymph node palpation | Normal | 45 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Respiratory system | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Musculoskeletal system | Abnormal NCS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Respiratory system | Normal | 45 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Skin | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Respiratory system | Abnormal NCS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Musculoskeletal system | Abnormal CS | 2 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Lymph node palpation | Abnormal NCS | 2 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Cardiovascular system | Normal | 46 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Nervous system | Normal | 46 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Cardiovascular system | Abnormal NCS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Skin | Normal | 44 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Cardiovascular system | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Nervous system | Abnormal NCS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Cardiovascular system | Normal | 44 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Lymph node palpation | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Cardiovascular system | Abnormal NCS | 1 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Nervous system | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Cardiovascular system | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Skin | Abnormal NCS | 1 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Gastrointestinal system | Normal | 46 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Nervous system | Normal | 45 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Gastrointestinal system | Abnormal NCS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Lymph node palpation | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 0: Gastrointestinal system | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Nervous system | Abnormal NCS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Gastrointestinal system | Normal | 45 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Skin | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Gastrointestinal system | Abnormal NCS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Nervous system | Abnormal CS | 0 Participants |
| Somapacitan | Change in Physical Examination | Week 52: Gastrointestinal system | Abnormal CS | 0 Participants |
Secondary
Change in Pulse
Change from baseline (week 0) in pulse at week 52 is presented.
Time frame: Week 0, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Pulse | -1.1 Beats per minute | Standard Deviation 7.5 |
| Somapacitan | Change in Pulse | 1.4 Beats per minute | Standard Deviation 8.9 |
Secondary
Change in SBP and DBP
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 52 is presented.
Time frame: Week 0, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Norditropin® | Change in SBP and DBP | SBP | -3.1 Millimeters of mercury (mmHg) | Standard Deviation 14.8 |
| Norditropin® | Change in SBP and DBP | DBP | 1.1 Millimeters of mercury (mmHg) | Standard Deviation 9.7 |
| Somapacitan | Change in SBP and DBP | SBP | -3.3 Millimeters of mercury (mmHg) | Standard Deviation 11.7 |
| Somapacitan | Change in SBP and DBP | DBP | 0.9 Millimeters of mercury (mmHg) | Standard Deviation 8.7 |
Secondary
Change in Steady State Beta Cell Function
Change from baseline (week -3) in steady state beta cell function (%B) at week 52 is presented.
Time frame: Week -3, week 52
Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Steady State Beta Cell Function | -23.58 Percentage of beta cell function (%B) | Standard Deviation 69.76 |
| Somapacitan | Change in Steady State Beta Cell Function | -19.06 Percentage of beta cell function (%B) | Standard Deviation 65.61 |
Secondary
Change in Subcutaneous Adipose Tissue Compartments
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.
Time frame: Week 0, week 52
Population: FAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin® | Change in Subcutaneous Adipose Tissue Compartments | 6.779 cm^2 | Standard Deviation 22.9 |
| Somapacitan | Change in Subcutaneous Adipose Tissue Compartments | -5.033 cm^2 | Standard Deviation 40.735 |
Secondary
Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
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.
Time frame: Week 0, week 52
Population: FAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Norditropin® | Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores | Effectiveness | 3.6 Score on a scale | Standard Deviation 16.2 |
| Norditropin® | Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores | Convenience | 8.7 Score on a scale | Standard Deviation 9.9 |
| Norditropin® | Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores | Global satisfaction | 3.1 Score on a scale | Standard Deviation 11.1 |
| Somapacitan | Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores | Effectiveness | 7.9 Score on a scale | Standard Deviation 17.5 |
| Somapacitan | Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores | Convenience | 13.3 Score on a scale | Standard Deviation 17.3 |
| Somapacitan | Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores | Global satisfaction | 10.0 Score on a scale | Standard Deviation 16.8 |
Secondary
Incidence of Clinical Technical Complaints
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.
Time frame: Weeks 0 - 53
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of randomised treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Norditropin® | Incidence of Clinical Technical Complaints | 1 Participants |
| Somapacitan | Incidence of Clinical Technical Complaints | 0 Participants |
Secondary
Occurrence of Anti-hGH Antibodies
Number of participants with anti-human growth hormone (hGH) antibodies at baseline (week 0) and week 53 are presented.
Time frame: Weeks 0 - 53
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of randomised treatment. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Norditropin® | Occurrence of Anti-hGH Antibodies | Week 0 | 0 Participants |
| Norditropin® | Occurrence of Anti-hGH Antibodies | Week 53 | 0 Participants |
| Somapacitan | Occurrence of Anti-hGH Antibodies | Week 0 | 1 Participants |
| Somapacitan | Occurrence of Anti-hGH Antibodies | Week 53 | 0 Participants |
Secondary
Occurrence of Anti-somapacitan Antibodies
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.
Time frame: Weeks 0 - 53
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of randomised treatment. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Norditropin® | Occurrence of Anti-somapacitan Antibodies | Week 0 | 0 Participants |
| Norditropin® | Occurrence of Anti-somapacitan Antibodies | Week 53 | 0 Participants |