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)

June 23, 2020 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • København Ø, Denmark, 2100
        • Novo Nordisk Investigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • France
      • Angers, France, 49000
        • Novo Nordisk Investigational Site
      • Brest, France, 29609
        • Novo Nordisk Investigational Site
      • Bron, France, 69677
        • Novo Nordisk Investigational Site
      • DIJON cedex, France, 21079
        • Novo Nordisk Investigational Site
      • Saint Herblain, France, 44800
        • Novo Nordisk Investigational Site
  • Germany
      • Aachen, Germany, 52074
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 10117
        • Novo Nordisk Investigational Site
      • Frankfurt, Germany, 60596
        • Novo Nordisk Investigational Site
  • Japan
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Novo Nordisk Investigational Site
      • Itabashi-ku, Tokyo, Japan, 173-8606
        • Novo Nordisk Investigational Site
      • Izumo, Shimane, Japan, 691-8501
        • Novo Nordisk Investigational Site
      • Kobe, Hyogo, Japan, 650-0017
        • Novo Nordisk Investigational Site
      • Kobe-shi, Hyogo, Japan, 657-0846
        • Novo Nordisk Investigational Site
      • Kyoto-shi Kyoto, Japan, 612-8555
        • Novo Nordisk Investigational Site
      • Okayama, Okayama, Japan, 700-8558
        • Novo Nordisk Investigational Site
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Novo Nordisk Investigational Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 171 76
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Novo Nordisk Investigational Site
      • Exeter, United Kingdom, EX2 5DW
        • Novo Nordisk Investigational Site
      • Leeds, United Kingdom, LS9 7TF
        • Novo Nordisk Investigational Site
      • London, United Kingdom, EC1A 7BE
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE5 9RS
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M20 4BX
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: somapacitan
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.
Active Comparator: hGH (somatropin)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Weeks 0 - 26
Incidence of Injection Site Reactions
Time Frame: Weeks 0- 26
Presented results are event (injection site reaction) rate per 100 patient years of exposure.
Weeks 0- 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Baseline (week 0), week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2015

Primary Completion (Actual)

January 4, 2016

Study Completion (Actual)

January 4, 2016

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8640-4043
  • 2014-000290-39 (EudraCT Number)
  • U1111-1152-3664 (Other Identifier: WHO)
  • JapicCTI-152850 (Other Identifier: JAPIC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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