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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 (REAL 2)

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ClinicalTrials.gov Identifier: NCT02382939
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : June 16, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE February 10, 2015
First Posted Date  ICMJE March 9, 2015
Results First Submitted Date  ICMJE May 1, 2020
Results First Posted Date  ICMJE June 16, 2020
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE February 12, 2015
Actual Primary Completion Date January 4, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • Incidence of Adverse Events [ Time Frame: Weeks 0 - 26 ]
    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.
  • Incidence of Injection Site Reactions [ Time Frame: Weeks 0- 26 ]
    Presented results are event (injection site reaction) rate per 100 patient years of exposure.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Incidence of Adverse Events [ Time Frame: Weeks 0 - 26 ]
  • Incidence of Injection Site Reactions [ Time Frame: Weeks 0- 26 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • Occurrence of Anti-NNC0195-0092 Antibodies [ Time Frame: At week 0 (baseline), and at week 2, 4, 8, 16, 25 and 27 ]
    Number of participants with anti-somapacitan (NNC0195-0092) antibodies are presented.
  • Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores (Effectiveness,Convenience, and Global Satisfaction Scores) [ Time Frame: Baseline (week 0), week 26 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Occurrence of Anti-NNC0195-0092 Antibodies [ Time Frame: Baseline, week 26 ]
  • Treatment Satisfaction Questionnaire for Medication (TSQM) scores (effectiveness,convenience, and global satisfaction scores) [ Time Frame: Baseline, week 26 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adult Growth Hormone Deficiency
  • Growth Hormone Disorder
Intervention  ICMJE
  • 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.
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: somapacitan
    Intervention: Drug: somapacitan
  • Active Comparator: hGH (somatropin)
    Intervention: Drug: somatropin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2016)
92
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2015)
90
Actual Study Completion Date  ICMJE January 4, 2016
Actual Primary Completion Date January 4, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   France,   Germany,   Japan,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02382939
Other Study ID Numbers  ICMJE NN8640-4043
2014-000290-39 ( EudraCT Number )
U1111-1152-3664 ( Other Identifier: WHO )
JapicCTI-152850 ( Other Identifier: JAPIC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP