A Trial to Compare the Safety of Once Weekly Dosing of So... | NCT02382939

NCT02382939

ID	Type	Description
2014-000290-39	EudraCT Number
U1111-1152-3664	Other Identifier	WHO
JapicCTI-152850	Other Identifier	JAPIC

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
somapacitan	Experimental		Drug: somapacitan
hGH (somatropin)	Active Comparator		Drug: somatropin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
somapacitan	Drug	Administered subcutaneously (s.c., under the skin) with an investigational pen once weekly for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events	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.	Weeks 0 - 26
Incidence of Injection Site Reactions	Presented results are event (injection site reaction) rate per 100 patient years of exposure.	Weeks 0- 26

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of Anti-NNC0195-0092 Antibodies	Number of participants with anti-somapacitan (NNC0195-0092) antibodies are presented.	At week 0 (baseline), and at week 2, 4, 8, 16, 25 and 27
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores (Effectiveness,Convenience, and Global Satisfaction Scores)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Århus C		8000	Denmark
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36380045	Derived	Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.

Label	URL
Clinical Trials at Novo Nordisk	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Full analysis set (FAS): all randomised participants that received at least one dose of randomised treatment.

Arm/Group Information

ID	Title	Description
BG000	Norditropin	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).
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00051.7± 17.1 BG00148.1± 16.2 BG00249.3± 16.5

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
18-64 years	BG00023 BG00150 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014 BG00128 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence of Adverse Events

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.

Safety analysis set: all randomised participants that received at least one dose of randomised treatment.

Posted

Number

Events per 100 patient years

Weeks 0 - 26

ID	Title	Description
OG000	Norditropin	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).
OG001	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.

Units	Counts
Participants	OG00031 OG00161

Title

Denominators

Categories

Title	Measurements
	OG000530.8 OG001514.2

Primary

Incidence of Injection Site Reactions

Presented results are event (injection site reaction) rate per 100 patient years of exposure.

Safety analysis set: all randomised participants that received at least one dose of randomised treatment.

Posted

Number

Events per 100 patient years

Weeks 0- 26

ID	Title	Description
OG000	Norditropin	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).
OG001	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.

Secondary

Occurrence of Anti-NNC0195-0092 Antibodies

Number of participants with anti-somapacitan (NNC0195-0092) antibodies are presented.

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.

Posted

Count of Participants

Participants

At week 0 (baseline), and at week 2, 4, 8, 16, 25 and 27

ID	Title	Description
OG000	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.

Units	Counts

Secondary

Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores (Effectiveness,Convenience, and Global Satisfaction Scores)

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.

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.

Posted

Mean

Standard Deviation

Score on a scale

Baseline (week 0), week 26

ID	Title	Description
OG000	Norditropin	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).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Norditropin	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.			2	31	18	31
EG001	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.			4	61	30	61

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected61 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected61 at risk
Mammoplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected61 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected61 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected61 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected61 at risk
Short-bowel syndrome	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected61 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected31 at risk EG0014 events4 affected61 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected31 at risk EG0015 events5 affected61 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected31 at risk EG0015 events4 affected61 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 events2 affected31 at risk EG0010 events0 affected61 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected31 at risk EG0011 events1 affected61 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0005 events5 affected31 at risk EG0017 events6 affected61 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA	Systematic Assessment	EG0002 events2 affected31 at risk EG0010 events0 affected61 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00010 events6 affected31 at risk EG00111 events7 affected61 at risk
Hypothyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0002 events2 affected31 at risk EG0011 events1 affected61 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00011 events8 affected31 at risk EG00113 events12 affected61 at risk
Sciatica	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected31 at risk EG0014 events4 affected61 at risk

ID	Term
D004393	Dwarfism, Pituitary

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D001849	Bone Diseases, Endocrine
D007018	Hypopituitarism
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D004700	Endocrine System Diseases

ID	Term
C000718308	somapacitan
D019382	Human Growth Hormone

Ancestor Terms

ID	Term
D013006	Growth Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins