| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-050137 | Registry Identifier | JAPIC | |
| JapicCTI-050132 | Registry Identifier | JAPIC | |
| 2017-000914-47 | Registry Identifier | EudraCT |
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This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan.
In the main period, subjects will receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks (two years) will continue with the same treatment for further 156 weeks (three years) while those subjects who received no treatment for 52 weeks (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In total, subjects participate in trial for 260 weeks (five years).
Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.033 mg / NN-220 | Experimental | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
|
| 0.067 mg / NN-220 | Experimental | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
|
| No treatment | No Intervention | No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period | |
| No treatment --> 0.033 mg | Experimental | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
|
| No treatment --> 0.067 mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | 0.033 mg/kg/day of NN-220 for s.c. injection in cartridge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit | Week 0, week 260 |
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit | Week 0, week 208 |
| Measure | Description | Time Frame |
|---|---|---|
| Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Yearly Height velocity SDS for chronological age were summarised and graphically presented | Weeks 0-260 |
| Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Tokyo | 1000005 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22156542 | Result | Tanaka T, Yokoya S, Seino Y, Togari H, Mishina J, Kappelgaard AM, Fujieda K. Long-term efficacy and safety of two doses of growth hormone in short Japanese children born small for gestational age. Horm Res Paediatr. 2011;76(6):411-8. doi: 10.1159/000334152. Epub 2011 Nov 29. | |
| 24526136 | Result | Kappelgaard AM, Kiyomi F, Horikawa R, Yokoya S, Tanaka T. The impact of long-term growth hormone treatment on metabolic parameters in Japanese patients with short stature born small for gestational age. Horm Res Paediatr. 2014;81(4):272-9. doi: 10.1159/000358196. Epub 2014 Feb 11. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Subjects completed the main period and were offered to continue in the extension period.
44 sites in Japan
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.033 mg / NN-220 | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
| FG001 | 0.067 mg / NN-220 | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
| FG002 | No Treatment | No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period |
| FG003 | No Treatment --> 0.033 mg | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| FG004 | No Treatment --> 0.067 mg | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Period (GHLIQUID-1516) |
| ||||||||||||||||
| Extension Period (GHLIQUID-1517) |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.033 mg / NN-220 | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Posted | Least Squares Mean | Standard Error | Standard Deviation Score (SDS) | Week 0, week 260 |
|
The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.033 mg / NN-220 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
Not provided
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
| somatropin | Drug | 0.067 mg/kg/day of NN-220 for s.c. injection in cartridge |
|
Yearly Height velocity SDS for chronological age were summarised and graphically presented |
| Weeks 0-208 |
| Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52*i weeks - Bone age at 52*(i-1) weeks, i=1, 2, …. | Week 0, week 260 |
| Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52*i weeks - Bone age at 52*(i-1) weeks, i=1, 2, …. | Week 0, week 208 |
| Adverse Events - Subjects Received NN220 Treatment for 5 Years | Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly | Weeks 0-260 |
| Adverse Events - Subjects Received NN220 Treatment for 4 Years | Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly | Weeks 0-208 |
| 27799945 | Derived | Horikawa R, Tanaka T, Nishinaga H, Ogawa Y, Yokoya S. The influence of a long-term growth hormone treatment on lipid and glucose metabolism: a randomized trial in short Japanese children born small for gestational age. Int J Pediatr Endocrinol. 2016;2016:19. doi: 10.1186/s13633-016-0036-4. Epub 2016 Oct 26. |
| COMPLETED |
|
| NOT COMPLETED |
|
| 0.067 mg / NN-220 |
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
| BG002 | No Treatment | No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Body weight | Mean | Standard Deviation | kg |
|
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
| OG001 | 0.067 mg / NN-220 | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
| OG002 | No Treatment --> 0.033 mg | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| OG003 | No Treatment --> 0.067 mg | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
|
|
| Primary | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Posted | Least Squares Mean | Standard Error | Standard Deviation Score (SDS) | Week 0, week 208 |
|
|
|
| Secondary | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Yearly Height velocity SDS for chronological age were summarised and graphically presented | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Posted | Mean | Standard Deviation | Standard Deviation Score (SDS) | Weeks 0-260 |
|
|
|
| Secondary | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Yearly Height velocity SDS for chronological age were summarised and graphically presented | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Posted | Mean | Standard Deviation | Standard Deviation Score (SDS) | Weeks 0-208 |
|
|
|
| Secondary | Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52*i weeks - Bone age at 52*(i-1) weeks, i=1, 2, …. | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Posted | Mean | Standard Deviation | years | Week 0, week 260 |
|
|
|
| Secondary | Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52*i weeks - Bone age at 52*(i-1) weeks, i=1, 2, …. | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Posted | Mean | Standard Deviation | years | Week 0, week 208 |
|
|
|
| Secondary | Adverse Events - Subjects Received NN220 Treatment for 5 Years | Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly | Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Posted | Number | Subjects | Weeks 0-260 |
|
|
|
| Secondary | Adverse Events - Subjects Received NN220 Treatment for 4 Years | Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly | Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Posted | Number | Subjects | Weeks 0-208 |
|
|
|
| 12 |
| 31 |
| 31 |
| 31 |
| EG001 | 0.067 mg / NN-220 | 11 | 34 | 34 | 34 |
| EG002 | 0.033 mg / No Treatment | 1 | 7 | 7 | 7 |
| EG003 | 0.067 mg / No Treatment | 2 | 8 | 8 | 8 |
| Aortic stenosis | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| IgA nephropathy | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Mumps | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Sebaceous naevus | Congenital, familial and genetic disorders | MedDRA 12 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Strabismus | Eye disorders | MedDRA 12 | Systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Testicular retraction | Reproductive system and breast disorders | MedDRA 12 | Systematic Assessment |
|
| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Tracheobronchitis mycoplasmal | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Adenoviral conjunctivitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Antibody test positive | Investigations | MedDRA 12 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Astigmatism | Eye disorders | MedDRA 12 | Systematic Assessment |
|
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 12 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 12 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 12 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 12 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Enterobiasis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Enterocolitis viral | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Enuresis | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 12 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 12 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Fibromatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 12 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 12 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 12 | Systematic Assessment |
|
| Hyperinsulinaemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
|
| Lymphadenitis bacterial | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Motion sickness | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
|
| Mumps | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Myopia | Eye disorders | MedDRA 12 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Rhinitis seasonal | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 12 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Strabismus | Eye disorders | MedDRA 12 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 12 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Week 104, n=29, 32 |
|
| Week 156, n=25, 29 |
|
| Week 208, n=25, 28 |
|
| Week 260, n=23, 27 |
|
| Week 104, n=6, 7 |
|
| Week 156, n=6, 7 |
|
| Week 208, n=6, 6 |
|
| SAEs |
|
| SAEs |
|