Height Velocity
| Group | Value (Cm/year (centimeter per year)) | Spread |
|---|---|---|
| Norditropin | 10.5 | 2.3 |
| Somapacitan | 11.0 | 2.1 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataChina
1 trial · 1 completed · 1 with posted results
A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.
NCT0497065422 Jul 2021 to 18 Dec 2023
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Somapacitan weekly
participants will receive once-weekly somapacitan for 52 weeks
Active comparator
Norditropin® daily
Participants will receive Norditropin® daily for 52 weeks
Outcomes the sponsor listed as primary.
Height Velocity
Time frame · Baseline (Week 0); Week 52
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).
Change in Bone Age
Time frame · Week -2, week 52
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.
Change in Height Standard Deviation Score
Time frame · Baseline (week 0), week 52
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.
Change in Height Velocity Standard Deviation Score
Time frame · Baseline (week 0), week 52
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.
Change in Fasting Plasma Glucose
Time frame · Baseline (week 0), week 52
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.
Change in HbA1c
Time frame · Baseline (week 0), week 52
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.
Change in IGF-I Standard Deviation Score
Time frame · Baseline (week 0), week 52
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.
Change in IGFBP-3 Standard Deviation Score
Time frame · Baseline (week 0), week 52
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Cm/year (centimeter per year)) | Spread |
|---|---|---|
| Norditropin | 10.5 | 2.3 |
| Somapacitan | 11.0 | 2.1 |
| Group | Value (Years) | Spread |
|---|---|---|
| Norditropin | 5.6 | 2.2 |
| Somapacitan | 5.5 | 2.1 |
| Group | Value (Score on a scale) | Spread |
|---|---|---|
| Norditropin | 1.13 | 0.48 |
| Somapacitan | 1.21 | 0.46 |
| Group | Value (Score on a scale) | Spread |
|---|---|---|
| Norditropin | 8.34 | 3.01 |
| Somapacitan | 8.96 | 3.53 |
| Group | Value (mmol/l (milimoles per liter)) | Spread |
|---|---|---|
| Norditropin | 0.541 | 0.523 |
| Somapacitan | 0.304 | 0.521 |
| Group | Value (Percentage (%) of HbA1c) | Spread |
|---|---|---|
| Norditropin | 0.09 | 0.31 |
| Somapacitan | 0.19 | 0.25 |
| Group | Value (Score on a scale) | Spread |
|---|---|---|
| Norditropin | 1.73 | 1.00 |
| Somapacitan | 2.09 | 1.28 |
| Group | Value (Score on a scale) | Spread |
|---|---|---|
| Norditropin | 0.93 | 0.75 |
| Somapacitan | 1.06 | 0.87 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| NorditropinParticipants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks. | 0 / 36 | 1 / 36 | 29 / 36 |
| SomapacitanParticipants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks. | 0 / 74 | 8 / 74 | 60 / 74 |
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