Trial Outcomes & Findings for A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency (NCT NCT02382939)
NCT ID: NCT02382939
Last Updated: 2020-07-09
Results Overview
An adverse event can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Presented results are event rate per 100 patient years of exposure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
92 participants
Primary outcome timeframe
Weeks 0 - 26
Results posted on
2020-07-09
Participant Flow
The trial was conducted at 26 sites in 6 countries. All 26 sites screened and randomised/ assigned patients to treatment. Denmark: 3 sites; France: 5 sites; Germany: 3 sites; Sweden: 3 sites; United Kingdom: 5 sites; Japan: 7 sites.
Participants, who were diagnosed with adults with growth hormone deficiency ≥ 6 months (defined as 180 days) prior to screening and receiving treatment with human growth hormone at least 6 months (defined as 180 days) at screening, were enrolled.
Participant milestones
| Measure |
Norditropin
Participants received subcutaneous (s.c.) injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on insulin-like growth factor-I standard deviation score (IGF-I SDS) values:
IGF-I SDS \> 3: dose reduction by 0.1 mg/day 2 \< IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 \< IGF-I SDS ≤ 2: No need of dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum daily dose was set to 0.05 mg and 1.1 mg (Japan: maximum daily dose was 1.0 mg).
|
Somapacitan
Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 1 mg 2 \< IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 \< IGF-I SDS ≤ 2: No need for dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
61
|
|
Overall Study
Exposed
|
31
|
61
|
|
Overall Study
COMPLETED
|
28
|
58
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Norditropin
Participants received subcutaneous (s.c.) injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on insulin-like growth factor-I standard deviation score (IGF-I SDS) values:
IGF-I SDS \> 3: dose reduction by 0.1 mg/day 2 \< IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 \< IGF-I SDS ≤ 2: No need of dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum daily dose was set to 0.05 mg and 1.1 mg (Japan: maximum daily dose was 1.0 mg).
|
Somapacitan
Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 1 mg 2 \< IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 \< IGF-I SDS ≤ 2: No need for dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
Baseline characteristics by cohort
| Measure |
Norditropin
n=31 Participants
Participants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 0.1 mg/day 2 \< IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 \< IGF-I SDS ≤ 2: No need of dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum daily dose was set to 0.05 mg and 1.1 mg (Japan: maximum daily dose was 1.0 mg).
|
Somapacitan
n=61 Participants
Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 1 mg 2 \< IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 \< IGF-I SDS ≤ 2: No need for dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 16.2 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Age, Customized
18-64 years
|
23 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 0 - 26Population: Safety analysis set: all randomised participants that received at least one dose of randomised treatment.
An adverse event can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Presented results are event rate per 100 patient years of exposure.
Outcome measures
| Measure |
Norditropin
n=31 Participants
Participants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 0.1 mg/day 2 \< IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 \< IGF-I SDS ≤ 2: No need of dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum daily dose was set to 0.05 mg and 1.1 mg (Japan: maximum daily dose was 1.0 mg).
|
Somapacitan
n=61 Participants
Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 1 mg 2 \< IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 \< IGF-I SDS ≤ 2: No need for dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.
|
|---|---|---|
|
Incidence of Adverse Events
|
530.8 Events per 100 patient years
|
514.2 Events per 100 patient years
|
PRIMARY outcome
Timeframe: Weeks 0- 26Population: Safety analysis set: all randomised participants that received at least one dose of randomised treatment.
Presented results are event (injection site reaction) rate per 100 patient years of exposure.
Outcome measures
| Measure |
Norditropin
n=31 Participants
Participants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 0.1 mg/day 2 \< IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 \< IGF-I SDS ≤ 2: No need of dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum daily dose was set to 0.05 mg and 1.1 mg (Japan: maximum daily dose was 1.0 mg).
|
Somapacitan
n=61 Participants
Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 1 mg 2 \< IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 \< IGF-I SDS ≤ 2: No need for dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.
|
|---|---|---|
|
Incidence of Injection Site Reactions
|
0 Events per 100 patient years
|
6.5 Events per 100 patient years
|
SECONDARY outcome
Timeframe: At week 0 (baseline), and at week 2, 4, 8, 16, 25 and 27Population: Overall Number of Participants Analyzed = safety analysis set which included all randomised participants that received at least one dose of randomised treatment. Number Analyzed = number of participants with available data. This outcome measure is applicable only for the somapacitan treatment arm.
Number of participants with anti-somapacitan (NNC0195-0092) antibodies are presented.
Outcome measures
| Measure |
Norditropin
n=61 Participants
Participants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 0.1 mg/day 2 \< IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 \< IGF-I SDS ≤ 2: No need of dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum daily dose was set to 0.05 mg and 1.1 mg (Japan: maximum daily dose was 1.0 mg).
|
Somapacitan
Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 1 mg 2 \< IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 \< IGF-I SDS ≤ 2: No need for dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.
|
|---|---|---|
|
Occurrence of Anti-NNC0195-0092 Antibodies
Week 0:
|
0 Participants
|
—
|
|
Occurrence of Anti-NNC0195-0092 Antibodies
Week 2:
|
0 Participants
|
—
|
|
Occurrence of Anti-NNC0195-0092 Antibodies
Week 4:
|
0 Participants
|
—
|
|
Occurrence of Anti-NNC0195-0092 Antibodies
Week 8:
|
0 Participants
|
—
|
|
Occurrence of Anti-NNC0195-0092 Antibodies
Week 16:
|
0 Participants
|
—
|
|
Occurrence of Anti-NNC0195-0092 Antibodies
Week 25:
|
0 Participants
|
—
|
|
Occurrence of Anti-NNC0195-0092 Antibodies
Week 27:
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (week 0), week 26Population: Overall Number of Participants Analyzed = full analysis set which included all randomised participants that received at least one dose of randomised treatment. Number Analyzed = number of participants with available data.
The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. Items are rated on a 5 or 7-point scale according to participants' experience with the medication. Each domain score can vary from 0 to 100 with higher scores indicating higher effectiveness of treatment, more convenient use of medication and overall greater satisfaction with the treatment.
Outcome measures
| Measure |
Norditropin
n=31 Participants
Participants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 0.1 mg/day 2 \< IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 \< IGF-I SDS ≤ 2: No need of dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum daily dose was set to 0.05 mg and 1.1 mg (Japan: maximum daily dose was 1.0 mg).
|
Somapacitan
n=61 Participants
Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 1 mg 2 \< IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 \< IGF-I SDS ≤ 2: No need for dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.
|
|---|---|---|
|
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores (Effectiveness,Convenience, and Global Satisfaction Scores)
Global satisfaction
|
-1.2 Score on a scale
Standard Deviation 15.2
|
5.4 Score on a scale
Standard Deviation 21.0
|
|
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores (Effectiveness,Convenience, and Global Satisfaction Scores)
Effectiveness
|
3.8 Score on a scale
Standard Deviation 27.4
|
9.7 Score on a scale
Standard Deviation 18.1
|
|
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores (Effectiveness,Convenience, and Global Satisfaction Scores)
Convenience
|
3.0 Score on a scale
Standard Deviation 16.5
|
15.3 Score on a scale
Standard Deviation 20.9
|
Adverse Events
Norditropin
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Somapacitan
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Norditropin
n=31 participants at risk
Participants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 0.1 mg/day 2 \< IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 \< IGF-I SDS ≤ 2: No need of dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed.
|
Somapacitan
n=61 participants at risk
Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 1 mg 2 \< IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 \< IGF-I SDS ≤ 2: No need for dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/31 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
1.6%
1/61 • Number of events 1 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
3.2%
1/31 • Number of events 1 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
0.00%
0/61 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Surgical and medical procedures
Mammoplasty
|
0.00%
0/31 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
1.6%
1/61 • Number of events 1 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.2%
1/31 • Number of events 1 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
0.00%
0/61 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/31 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
1.6%
1/61 • Number of events 1 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/31 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
1.6%
1/61 • Number of events 1 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Gastrointestinal disorders
Short-bowel syndrome
|
3.2%
1/31 • Number of events 1 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
0.00%
0/61 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
Other adverse events
| Measure |
Norditropin
n=31 participants at risk
Participants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 0.1 mg/day 2 \< IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 \< IGF-I SDS ≤ 2: No need of dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed.
|
Somapacitan
n=61 participants at risk
Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:
IGF-I SDS \> 3: dose reduction by 1 mg 2 \< IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 \< IGF-I SDS ≤ 2: No need for dose adjustment
* 2 \< IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/31 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
6.6%
4/61 • Number of events 4 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
2/31 • Number of events 2 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
8.2%
5/61 • Number of events 5 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
General disorders
Asthenia
|
3.2%
1/31 • Number of events 1 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
6.6%
4/61 • Number of events 5 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Psychiatric disorders
Depression
|
6.5%
2/31 • Number of events 2 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
0.00%
0/61 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Nervous system disorders
Dizziness
|
9.7%
3/31 • Number of events 3 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
1.6%
1/61 • Number of events 1 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
General disorders
Fatigue
|
16.1%
5/31 • Number of events 5 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
9.8%
6/61 • Number of events 7 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.5%
2/31 • Number of events 2 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
0.00%
0/61 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Nervous system disorders
Headache
|
19.4%
6/31 • Number of events 10 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
11.5%
7/61 • Number of events 11 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
6.5%
2/31 • Number of events 2 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
1.6%
1/61 • Number of events 1 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
25.8%
8/31 • Number of events 11 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
19.7%
12/61 • Number of events 13 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/31 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
6.6%
4/61 • Number of events 4 • Baseline (week 0) to week 26.
Participants in the safety analysis set contributed to the evaluation of adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER