This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in previously human growth hormone (hGH) treated adults with growth hormone deficiency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
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.
Administered subcutaneously (s.c., under the skin) with a prefilled pen (Norditropin® FlexPro®) daily for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.
Novo Nordisk Investigational Site
Århus C, Denmark
Novo Nordisk Investigational Site
København Ø, Denmark
Novo Nordisk Investigational Site
Odense, Denmark
Novo Nordisk Investigational Site
Angers, France
Novo Nordisk Investigational Site
Brest, France
Novo Nordisk Investigational Site
Bron, France
Novo Nordisk Investigational Site
Dijon, France
Novo Nordisk Investigational Site
Saint-Herblain, France
Novo Nordisk Investigational Site
Aachen, Germany
Novo Nordisk Investigational Site
Berlin, Germany
...and 18 more locations
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.
Time frame: Weeks 0 - 26
Incidence of Injection Site Reactions
Presented results are event (injection site reaction) rate per 100 patient years of exposure.
Time frame: Weeks 0- 26
Occurrence of Anti-NNC0195-0092 Antibodies
Number of participants with anti-somapacitan (NNC0195-0092) antibodies are presented.
Time frame: 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)
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.
Time frame: Baseline (week 0), week 26
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