A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency

Conditions

Growth Hormone Deficiency in children

Brief summary

Endpoint title: Height velocity Time frame: From baseline (week 0) to visit 7 (week 52) Unit: cm/year

Detailed description

Effect Endpoint title: Change in bone age Time frame: From screening (visit 1) to visit 7 (week 52) Unit: Years, Effect Endpoint title: Change in Height Standard Deviation Score Time frame: From baseline (week 0) to visit 7 (week 52) Unit: -10 to +10, Effect Endpoint title: Change in Height Velocity SDS Time frame: From baseline (week 0) to visit 7 (week 52) Unit: -10 to +10, Safety Endpoint title: Change in fasting plasma glucose Time frame: From screening (visit 1) to visit 7 (week 52) From screening (visit 1) to visit 11 (week 104) From screening (visit 1) to visit 15 (week 156) From screening (visit 1) to visit 19 (week 208) Unit: mmol/L, Safety Endpoint title: Change in homeostatic model assessment (HOMA) Time frame: From screening (visit 1) to visit 7 (week 52) From screening (visit 1) to visit 11 (week 104) From screening (visit 1) to visit 15 (week 156) From screening (visit 1) to visit 19 (week 208) Unit: %, Safety Endpoint title: Change in Glycated haemoglobin (HbA1c) Time frame: From screening (visit 1) to visit 7 (week 52) From screening (visit 1) to visit 11 (week 104) From screening (visit 1) to visit 15 (week 156) From screening (visit 1) to visit 19 (week 208) Unit: % point, Pharmacodynamics Endpoint title: Change in IGF-I SDS Time frame: From baseline (week 0) to visit 7 (week 52) From baseline (week 0) to visit 11 (week 104) From baseline (week 0) to visit 15 (week 156) From baseline (week 0) to visit 19 (week 208) Unit: -10 to +10, Pharmacodynamics Endpoint title: Change in IGFBP-3 SDS Time frame: From baseline (week 0) to visit 7 (week 52) From baseline (week 0) to visit 11 (week 104) From baseline (week 0) to visit 15 (week 156) From baseline (week 0) to visit 19 (week 208) Unit: -10 to +10

Related papers

No related papers found yet.

Interventions

DRUGNorditropin FlexPro

DRUGSogroya 15 mg/1.5 mL solution for injection in pre-filled pen

DRUGSogroya 5 mg/1.5 mL solution for injection in pre-filled pen

DRUGSogroya 10 mg/1.5 mL solution for injection in pre-filled pen

DRUGinjektionsvæske

DRUGopløsning i fyldt pen

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Endpoint title: Height velocity Time frame: From baseline (week 0) to visit 7 (week 52) Unit: cm/year	—

Secondary

Measure	Time frame
Effect Endpoint title: Change in bone age Time frame: From screening (visit 1) to visit 7 (week 52) Unit: Years, Effect Endpoint title: Change in Height Standard Deviation Score Time frame: From baseline (week 0) to visit 7 (week 52) Unit: -10 to +10, Effect Endpoint title: Change in Height Velocity SDS Time frame: From baseline (week 0) to visit 7 (week 52) Unit: -10 to +10, Safety Endpoint title: Change in fasting plasma glucose Time frame: From screening (visit 1) to visit 7 (week 52) From screening (visit 1) to visit 11 (week 104) From screening (visit 1) to visit 15 (week 156) From screening (visit 1) to visit 19 (week 208) Unit: mmol/L, Safety Endpoint title: Change in homeostatic model assessment (HOMA) Time frame: From screening (visit 1) to visit 7 (week 52) From screening (visit 1) to visit 11 (week 104) From screening (visit 1) to visit 15 (week 156) From screening (visit 1) to visit 19 (week 208) Unit: %, Safety Endpoint title: Change in Glycated haemoglobin (HbA1c) Time fr	—

Measure

Time frame

Effect Endpoint title: Change in bone age Time frame: From screening (visit 1) to visit 7 (week 52) Unit: Years, Effect Endpoint title: Change in Height Standard Deviation Score Time frame: From baseline (week 0) to visit 7 (week 52) Unit: -10 to +10, Effect Endpoint title: Change in Height Velocity SDS Time frame: From baseline (week 0) to visit 7 (week 52) Unit: -10 to +10, Safety Endpoint title: Change in fasting plasma glucose Time frame: From screening (visit 1) to visit 7 (week 52) From screening (visit 1) to visit 11 (week 104) From screening (visit 1) to visit 15 (week 156) From screening (visit 1) to visit 19 (week 208) Unit: mmol/L, Safety Endpoint title: Change in homeostatic model assessment (HOMA) Time frame: From screening (visit 1) to visit 7 (week 52) From screening (visit 1) to visit 11 (week 104) From screening (visit 1) to visit 15 (week 156) From screening (visit 1) to visit 19 (week 208) Unit: %, Safety Endpoint title: Change in Glycated haemoglobin (HbA1c) Time fr

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Countries

Austria, France, Germany, Italy, Latvia, Poland, Slovenia, Spain

Outcome results

None listed