The study compares two medicines for children with a low level of hormone to grow: somapacitan (a new medicine) given once a week and Norditropin® (a medicine doctors can already prescribe) given once a day. Researchers will test somapacitan to see how well it works, compared to the standard treatment with Norditropin®. The participants will either get Norditropin® once every day or somapacitan once every week - which treatment the participant gets is decided by chance. The participant and the study doctor will know which treatment the participant gets. The study includes a 52 week treatment period and a minimum of 30 days follow up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Somapacitan (0.16 mg/kg/week) will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.
Norditropin® (0.034 mg/kg/day) will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Capital Center for Children's Health, Capital Medical University-Endocrinology
Beijing, Beijing Municipality, China
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University-Pediatric
Xiamen, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Height Velocity
Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years).
Time frame: Baseline (Week 0); Week 52
Change in Bone Age
Change in bone age is presented from week -2 to week 52. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Time frame: Week -2, week 52
Change in Height Standard Deviation Score
Change in the height standard deviation score (HSDS) is presented from baseline (week 0) to week 52. HSDS was derived using Chinese general population standards. The formula to calculate HSDS is: HSDS = ((Height / M)\*\*L-1) / (L\*S). L: The sex and age-specific power in the Box-Cox transformation, M: The sex and age-specific median, S: The sex and age-specific generalized coefficient of variation. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Time frame: Baseline (week 0), week 52
Change in Height Velocity Standard Deviation Score
Change in height velocity standard deviation score (HVSDS) is presented from baseline (week 0) to week 52. HVSDS was derived using Prader standards. HVSDS was calculated using the formula: HVSDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HVSDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Time frame: Baseline (week 0), week 52
Change in Fasting Plasma Glucose
Change in fasting plasma glucose is presented from baseline (week 0) to week 52. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Time frame: Baseline (week 0), week 52
Change in HbA1c
Change in glycosylated haemoglobin (HbA1c) is presented from baseline (week 0) to week 52 is presented. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Time frame: Baseline (week 0), week 52
Change in IGF-I Standard Deviation Score
Change in Insulin like growth factor-I (IGF-I) standard deviation score is presented from baseline (week 0) to week 52. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Time frame: Baseline (week 0), week 52
Change in IGFBP-3 Standard Deviation Score
Change in Insulin like growth factor binding protein 3 (IGFBP-3) standard deviation score is presented from baseline (week 0) to week 52. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Time frame: Baseline (week 0), week 52
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The Third Affiliated Hospital, Sun Yat-Sen University-Pediatric
Guangzhou, Guangdong, China
Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
Zhengzhou, Henan, China
Henan Children's Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College of HUST-Pediatric
Wuhan, Hubei, China
Hunan Children's Hospital-Child Health Center
Changsha, Hunan, China
...and 22 more locations