A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

Adult Growth Hormone Deficiency Clinical Trial

— REAL 2  

Official title:

A Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382939
• Other study ID #: NN8640-4043
• Secondary ID: 2014-000290-39U1
• Status: Completed
• Phase: Phase 3
• Start date: February 12, 2015
• Est. completion date: January 4, 2016

Study information

• Verified date: June 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 4, 2016
• Est. primary completion date: January 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - Adult growth hormone deficiency diagnosed for 6 months or longer (defined as 180 days) prior to screening - Treatment with hGH (human growth hormone) for at least 6 months at screening - If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. / Subjects with GHD (growth hormone deficiency) attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file - For patients with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years: Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery MRI or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Disorder

Intervention

Drug:
• somapacitan
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.
• somatropin
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.

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Århus C
Denmark	Novo Nordisk Investigational Site	København Ø
Denmark	Novo Nordisk Investigational Site	Odense
France	Novo Nordisk Investigational Site	Angers
France	Novo Nordisk Investigational Site	Brest
France	Novo Nordisk Investigational Site	Bron
France	Novo Nordisk Investigational Site	DIJON cedex
France	Novo Nordisk Investigational Site	Saint Herblain
Germany	Novo Nordisk Investigational Site	Aachen
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Frankfurt
Japan	Novo Nordisk Investigational Site	Bunkyo-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Itabashi-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Izumo, Shimane
Japan	Novo Nordisk Investigational Site	Kobe, Hyogo
Japan	Novo Nordisk Investigational Site	Kobe-shi, Hyogo
Japan	Novo Nordisk Investigational Site	Kyoto-shi Kyoto
Japan	Novo Nordisk Investigational Site	Okayama, Okayama
Japan	Novo Nordisk Investigational Site	Sagamihara-shi, Kanagawa
Sweden	Novo Nordisk Investigational Site	Göteborg
Sweden	Novo Nordisk Investigational Site	Lund
Sweden	Novo Nordisk Investigational Site	Stockholm
United Kingdom	Novo Nordisk Investigational Site	Birmingham
United Kingdom	Novo Nordisk Investigational Site	Exeter
United Kingdom	Novo Nordisk Investigational Site	Leeds
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Japan,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Weeks 0 - 26
Primary	Incidence of Injection Site Reactions	Presented results are event (injection site reaction) rate per 100 patient years of exposure.	Weeks 0- 26
Secondary	Occurrence of Anti-NNC0195-0092 Antibodies	Number of participants with anti-somapacitan (NNC0195-0092) antibodies are presented.	At week 0 (baseline), and at week 2, 4, 8, 16, 25 and 27
Secondary	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.	Baseline (week 0), week 26

External Links

•   Clinical Trials at Novo Nordisk