A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT03075644
Collaborator
(none)
62
12
2
19.1
5.2
0.3
Study Details
Study Description
Brief Summary
This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
Actual Study Start Date
:
Mar 3, 2017
Actual Primary Completion Date
:
Oct 4, 2018
Actual Study Completion Date
:
Oct 4, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Somapacitan
|
Drug: somapacitan
Once weekly subcutaneous injections (s.c., under the skin)
|
| Active Comparator: Norditropin
|
Drug: Norditropin
Daily subcutaneous injections (s.c., under the skin)
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events, Including Injection Site Reactions [Weeks 0-53]
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which did not necessarily have a causal relationship with the treatment. Rate of AEs per 100 patient years at risk with onset after the first administration of trial product and up until end of the trial (53 weeks) or 14 days after last trial drug administration, whichever came first, are presented.
Secondary Outcome Measures
- 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 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 Haematology: Mean Corpuscular Haemoglobin Concentration [Week -3, week 52]
Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented.
- Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) [Week -3, week 52]
Change from baseline (week -3) in creatinine, uric acid, and bilirubin (total) at week 52 is presented.
- Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT [Week -3, week 52]
Change from baseline (week -3) in creatinine kinase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) at week 52 is presented.
- Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) [Week -3, week 52]
Change from baseline (week -3) in urea, sodium, potassium, chloride, phosphate (inorganic), calcium (total) (mmol/L) at week 52 is presented.
- Change in 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 79 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Bunkyo-ku, Tokyo | Japan | 113-8603 | |
| 2 | Novo Nordisk Investigational Site | Chiba-shi, Chiba | Japan | 260-8677 | |
| 3 | Novo Nordisk Investigational Site | Fukuoka | Japan | 818 8502 | |
| 4 | Novo Nordisk Investigational Site | Kagoshima | Japan | 890-8520 | |
| 5 | Novo Nordisk Investigational Site | Kobe, Hyogo | Japan | 650-0017 | |
| 6 | Novo Nordisk Investigational Site | Kyoto-shi Kyoto | Japan | 612-8555 | |
| 7 | Novo Nordisk Investigational Site | Okayama, Okayama | Japan | 700-8558 | |
| 8 | Novo Nordisk Investigational Site | Osaka | Japan | 565-0871 | |
| 9 | Novo Nordisk Investigational Site | Sagamihara-shi, Kanagawa | Japan | 252-0375 | |
| 10 | Novo Nordisk Investigational Site | Tokyo | Japan | 134-0088 | |
| 11 | Novo Nordisk Investigational Site | Yamagata-shi, Yamagata | Japan | 990-9585 | |
| 12 | Novo Nordisk Investigational Site | Yokohama, Kanagawa | Japan | 222-0036 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT03075644
Other Study ID Numbers:
- NN8640-4244
- U1111-1181-1618
- JapicCTI-173534
First Posted:
Mar 9, 2017
Last Update Posted:
Nov 23, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The trial was conducted at 12 sites in Japan. |
|---|---|
| Pre-assignment Detail | Participants were randomised in a 3:1 manner to receive either somapacitan or Norditropin®. |
| Arm/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Period Title: Overall Study | ||
| STARTED | 16 | 46 |
| Full Analysis Set (FAS) | 16 | 46 |
| Safety Analysis Set (SAS) | 16 | 46 |
| COMPLETED | 15 | 45 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Norditropin® | Somapacitan | Total |
|---|---|---|---|
| Arm/Group Description | 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). | 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. | Total of all reporting groups |
| Overall Participants | 16 | 46 | 62 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
49.3
(11.5)
|
54.1
(12.1)
|
52.8
(12.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
7
43.8%
|
22
47.8%
|
29
46.8%
|
| Male |
9
56.3%
|
24
52.2%
|
33
53.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
16
100%
|
46
100%
|
62
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
16
100%
|
46
100%
|
62
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Incidence of Adverse Events, Including Injection Site Reactions |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (SAS) which comprised all randomised participants who received at least one dose of randomised treatment. |
| Arm/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 16 | 46 |
| Number [Event rate per 100 patient years] |
309.8
|
312.7
|
| Title | Change in Cross-sectional Total Adipose Tissue Compartments |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 43 |
| Mean (Standard Deviation) [Square centimeters (cm^2)] |
7.450
(32.177)
|
-7.091
(58.893)
|
| Title | Change in Subcutaneous Adipose Tissue Compartments |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 43 |
| Mean (Standard Deviation) [cm^2] |
6.779
(22.900)
|
-5.033
(40.735)
|
| Title | Change in Intra-abdominal or Visceral Adipose Tissue Compartments |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [cm^2] |
0.671
(15.284)
|
-2.618
(29.123)
|
| Title | Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Effectiveness |
3.6
(16.2)
|
7.9
(17.5)
|
| Convenience |
8.7
(9.9)
|
13.3
(17.3)
|
| Global satisfaction |
3.1
(11.1)
|
10.0
(16.8)
|
| Title | Change in Physical Examination |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 16 | 46 |
| Normal |
15
93.8%
|
45
97.8%
|
| Abnormal NCS |
0
0%
|
1
2.2%
|
| Abnormal CS |
1
6.3%
|
0
0%
|
| Normal |
14
87.5%
|
43
93.5%
|
| Abnormal NCS |
0
0%
|
1
2.2%
|
| Abnormal CS |
1
6.3%
|
1
2.2%
|
| Normal |
16
100%
|
46
100%
|
| Abnormal NCS |
0
0%
|
0
0%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
15
93.8%
|
45
97.8%
|
| Abnormal NCS |
0
0%
|
0
0%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
16
100%
|
46
100%
|
| Abnormal NCS |
0
0%
|
0
0%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
15
93.8%
|
44
95.7%
|
| Abnormal NCS |
0
0%
|
1
2.2%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
15
93.8%
|
46
100%
|
| Abnormal NCS |
1
6.3%
|
0
0%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
15
93.8%
|
45
97.8%
|
| Abnormal NCS |
0
0%
|
0
0%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
16
100%
|
45
97.8%
|
| Abnormal NCS |
0
0%
|
1
2.2%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
15
93.8%
|
43
93.5%
|
| Abnormal NCS |
0
0%
|
0
0%
|
| Abnormal CS |
0
0%
|
2
4.3%
|
| Normal |
16
100%
|
46
100%
|
| Abnormal NCS |
0
0%
|
0
0%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
15
93.8%
|
45
97.8%
|
| Abnormal NCS |
0
0%
|
0
0%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
16
100%
|
46
100%
|
| Abnormal NCS |
0
0%
|
0
0%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
15
93.8%
|
44
95.7%
|
| Abnormal NCS |
0
0%
|
1
2.2%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
16
100%
|
44
95.7%
|
| Abnormal NCS |
0
0%
|
2
4.3%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
15
93.8%
|
45
97.8%
|
| Abnormal NCS |
0
0%
|
0
0%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Title | Change in Body Weight |
|---|---|
| Description | Change from baseline (week -3) in body weight at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [Kilogram (Kg)] |
0.66
(2.50)
|
-0.29
(3.49)
|
| Title | Change in SBP and DBP |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| SBP |
-3.1
(14.8)
|
-3.3
(11.7)
|
| DBP |
1.1
(9.7)
|
0.9
(8.7)
|
| Title | Change in Pulse |
|---|---|
| Description | Change from baseline (week 0) in pulse at week 52 is presented. |
| Time Frame | Week 0, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [Beats per minute] |
-1.1
(7.5)
|
1.4
(8.9)
|
| Title | Change in ECG |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 16 | 46 |
| Normal |
16
100%
|
39
84.8%
|
| Abnormal NCS |
0
0%
|
7
15.2%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Normal |
15
93.8%
|
37
80.4%
|
| Abnormal NCS |
0
0%
|
8
17.4%
|
| Abnormal CS |
0
0%
|
0
0%
|
| Title | Change in Haematology: Haemoglobin |
|---|---|
| Description | Change from baseline (week -3) in haemoglobin at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [Grams/liter (g/L)] |
-2.071
(7.790)
|
0.311
(6.026)
|
| Title | Change in Haematology: Haematocrit |
|---|---|
| Description | Change from baseline (week -3) in haematocrit at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [Percentage point of haematocrit] |
-0.64
(2.76)
|
0.04
(2.31)
|
| Title | Change in Haematology: Thrombocytes, Leucocytes |
|---|---|
| Description | Change from baseline (week -3) in thrombocytes and leucocytes at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 16 | 46 |
| Thrombocytes |
0.1
(27.7)
|
5.7
(33.5)
|
| Leucocytes |
-0.29
(1.01)
|
-0.50
(1.43)
|
| Title | Change in Haematology: Erythrocytes |
|---|---|
| Description | Change from baseline (week -3) in erythrocytes at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [cells per picoliter] |
-0.086
(0.271)
|
-0.007
(0.228)
|
| Title | Change in Haematology: Mean Corpuscular Volume |
|---|---|
| Description | Change from baseline (week -3) in mean corpuscular volume at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [Femtoliters (fL)] |
0.00
(2.45)
|
0.29
(1.91)
|
| Title | Change in Haematology: Mean Corpuscular Haemoglobin Concentration |
|---|---|
| Description | Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [Millimoles per liter (mmol/L)] |
0.04
(0.47)
|
0.05
(0.45)
|
| Title | Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) |
|---|---|
| Description | Change from baseline (week -3) in creatinine, uric acid, and bilirubin (total) at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Creatinine |
1.4
(7.8)
|
1.0
(7.4)
|
| Uric acid |
25.9
(41.9)
|
6.7
(49.9)
|
| Total bilirubin |
-0.21
(5.21)
|
0.56
(3.81)
|
| Title | Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Creatinine kinase |
-10.4
(66.8)
|
6.8
(261.3)
|
| ALT |
-4.9
(13.4)
|
-1.6
(9.4)
|
| AST |
-3.2
(10.3)
|
-1.4
(7.2)
|
| ALP |
-9.1
(11.0)
|
-0.7
(11.4)
|
| GGT |
-9.4
(19.2)
|
-0.6
(6.6)
|
| Title | Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Urea |
0.29
(0.83)
|
0.71
(1.29)
|
| Sodium |
-0.3
(1.9)
|
0.2
(2.8)
|
| Potassium |
-0.04
(0.29)
|
0.04
(0.34)
|
| Chloride |
0.4
(2.8)
|
0.6
(2.9)
|
| Inorganic phosphate |
0.000
(0.185)
|
0.028
(0.172)
|
| Total calcium |
-0.067
(0.068)
|
-0.051
(0.082)
|
| Title | Change in Biochemistry: Total Protein and Albumin |
|---|---|
| Description | Change from baseline (week -3) in total protein and albumin at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Total protein |
-0.6
(3.7)
|
1.4
(3.1)
|
| Albumin |
0.3
(2.8)
|
1.3
(2.4)
|
| Title | Change in Biochemistry: eGFR Creatinine |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [mL/min/1.73m^2] |
-1.4
(7.1)
|
-1.4
(6.2)
|
| Title | Change in HbA1c |
|---|---|
| Description | Change from baseline (week -3) in glycosylated haemoglobin (HbA1c) at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [Percentage point of HbA1c] |
-0.04
(0.22)
|
-0.07
(0.21)
|
| Title | Change in FPG |
|---|---|
| Description | Change from baseline (week -3) in fasting plasma glucose (FPG) (mmol/L) at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [mmol/L] |
0.014
(0.442)
|
0.089
(0.453)
|
| Title | Change in Fasting Insulin |
|---|---|
| Description | Change from baseline (week -3) in fasting insulin at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [Picomoles per liter (pmol/L)] |
-16.7
(54.1)
|
-8.7
(44.7)
|
| Title | Change in Steady State Beta Cell Function |
|---|---|
| Description | Change from baseline (week -3) in steady state beta cell function (%B) at week 52 is presented. |
| Time Frame | Week -3, week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 12 | 39 |
| Mean (Standard Deviation) [Percentage of beta cell function (%B)] |
-23.58
(69.76)
|
-19.06
(65.61)
|
| Title | Change in Insulin Resistance |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 14 | 45 |
| Mean (Standard Deviation) [Percentage (%) of IR] |
-0.60
(2.03)
|
-0.25
(1.70)
|
| Title | Occurrence of Anti-somapacitan Antibodies |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Somapacitan |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 46 |
| Week 0 |
0
0%
|
| Week 53 |
0
0%
|
| Title | Occurrence of Anti-hGH Antibodies |
|---|---|
| Description | Number of participants with anti-human growth hormone (hGH) antibodies at baseline (week 0) and week 53 are presented. |
| Time Frame | Weeks 0 - 53 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 16 | 46 |
| Week 0 |
0
0%
|
1
2.2%
|
| Week 53 |
0
0%
|
0
0%
|
| Title | Incidence of Clinical Technical Complaints |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of randomised treatment. |
| Arm/Group Title | Norditropin® | Somapacitan |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 16 | 46 |
| Count of Participants [Participants] |
1
6.3%
|
0
0%
|
Adverse Events
| Time Frame | Weeks 0 - 53 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 14 days after the last day of trial product administration. Results are based on the SAS which comprised all randomised participants who received at least one dose of randomised treatment. | |||
| Arm/Group Title | Norditropin® | Somapacitan | ||
| Arm/Group Description | 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). | 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. | ||
All Cause Mortality |
||||
| Norditropin® | Somapacitan | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | 0/46 (0%) | ||
Serious Adverse Events |
||||
| Norditropin® | Somapacitan | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | 4/46 (8.7%) | ||
| Gastrointestinal disorders | ||||
| Inguinal hernia | 0/16 (0%) | 0 | 1/46 (2.2%) | 1 |
| Large intestine polyp | 0/16 (0%) | 0 | 1/46 (2.2%) | 1 |
| Infections and infestations | ||||
| Gastroenteritis | 0/16 (0%) | 0 | 1/46 (2.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Head injury | 0/16 (0%) | 0 | 1/46 (2.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Norditropin® | Somapacitan | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/16 (68.8%) | 33/46 (71.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Eye disorders | ||||
| Cataract | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Gastric polyps | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Gastrooesophageal reflux disease | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Hiatus hernia | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| General disorders | ||||
| Chest pain | 1/16 (6.3%) | 1 | 1/46 (2.2%) | 1 |
| Fatigue | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Injection site haemorrhage | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Vessel puncture site bruise | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Infections and infestations | ||||
| Gingivitis | 0/16 (0%) | 0 | 3/46 (6.5%) | 3 |
| Influenza | 1/16 (6.3%) | 1 | 3/46 (6.5%) | 3 |
| Nasopharyngitis | 5/16 (31.3%) | 9 | 22/46 (47.8%) | 46 |
| Oral herpes | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Pharyngitis | 1/16 (6.3%) | 1 | 1/46 (2.2%) | 1 |
| Respiratory tract infection | 1/16 (6.3%) | 2 | 1/46 (2.2%) | 1 |
| Rhinitis | 0/16 (0%) | 0 | 3/46 (6.5%) | 3 |
| Upper respiratory tract infection | 1/16 (6.3%) | 2 | 0/46 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Contusion | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Meniscus injury | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/16 (6.3%) | 1 | 3/46 (6.5%) | 4 |
| Back pain | 1/16 (6.3%) | 2 | 2/46 (4.3%) | 2 |
| Myalgia | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 1/16 (6.3%) | 2 | 4/46 (8.7%) | 4 |
| Hypoaesthesia | 1/16 (6.3%) | 1 | 2/46 (4.3%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Epistaxis | 1/16 (6.3%) | 4 | 0/46 (0%) | 0 |
| Oropharyngeal pain | 1/16 (6.3%) | 1 | 1/46 (2.2%) | 1 |
| Rhinitis allergic | 1/16 (6.3%) | 1 | 1/46 (2.2%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Eczema | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Miliaria | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
| Rash | 3/16 (18.8%) | 3 | 0/46 (0%) | 0 |
| Skin hyperpigmentation | 1/16 (6.3%) | 1 | 0/46 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
| Name/Title | Clinical Reporting Anchor and Disclosure (1452) |
|---|---|
| Organization | Novo Nordisk A/S |
| Phone | (+1) 866-867-7178 |
| clinicaltrials@novonordisk.com |
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT03075644
Other Study ID Numbers:
- NN8640-4244
- U1111-1181-1618
- JapicCTI-173534
First Posted:
Mar 9, 2017
Last Update Posted:
Nov 23, 2020
Last Verified:
Nov 1, 2020