| 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. | Safety analysis set (SAS) which comprised all randomised participants who received at least one dose of randomised treatment. | Posted | | Number | | Event rate per 100 patient years | | Weeks 0-53 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Square centimeters (cm^2) | | Week 0, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | cm^2 | | Week 0, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | cm^2 | | Week 0, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Week 0, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Week 0, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Somapacitan | |
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| Secondary | Change in Body Weight | Change from baseline (week -3) in body weight at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | Kilogram (Kg) | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Week 0, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in Pulse | Change from baseline (week 0) in pulse at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | Beats per minute | | Week 0, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in Haematology: Haemoglobin | Change from baseline (week -3) in haemoglobin at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | Grams/liter (g/L) | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in Haematology: Haematocrit | Change from baseline (week -3) in haematocrit at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | Percentage point of haematocrit | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in Haematology: Thrombocytes, Leucocytes | Change from baseline (week -3) in thrombocytes and leucocytes at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in Haematology: Erythrocytes | Change from baseline (week -3) in erythrocytes at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | cells per picoliter | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in Haematology: Mean Corpuscular Volume | Change from baseline (week -3) in mean corpuscular volume at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | Femtoliters (fL) | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in Haematology: Mean Corpuscular Haemoglobin Concentration | Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | Millimoles per liter (mmol/L) | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Micromoles per liter (umol/L) | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Units per liter (U/L) | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in Biochemistry: Total Protein and Albumin | Change from baseline (week -3) in total protein and albumin at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | Grams/liter (g/L) | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mL/min/1.73m^2 | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in HbA1c | Change from baseline (week -3) in glycosylated haemoglobin (HbA1c) at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | Percentage point of HbA1c | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in FPG | Change from baseline (week -3) in fasting plasma glucose (FPG) (mmol/L) at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in Fasting Insulin | Change from baseline (week -3) in fasting insulin at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | Picomoles per liter (pmol/L) | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Percentage of beta cell function (%B) | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Change in Insulin Resistance | Change from baseline (week -3) in insulin resistance (IR) (Homeostatic model assessment (HOMA) estimates) at week 52 is presented. | 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. | Posted | | Mean | Standard Deviation | Percentage (%) of IR | | Week -3, week 52 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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". | 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. | Posted | | Count of Participants | | Participants | | Weeks 0 - 53 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Weeks 0 - 53 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of randomised treatment. | Posted | | Count of Participants | | Participants | | Weeks 0 - 53 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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