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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name REAL 2

NCTNCT02382939 (opens ClinicalTrials.gov in a new tab)Other idNN8640-4043Other id2014-000290-39Other idU1111-1152-3664Other idJapicCTI-152850
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
92 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
6 countries

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

Start
12 Feb 2015
Primary completion
4 Jan 2016
Completion
4 Jan 2016
First posted
9 Mar 2015 (estimated)
Last update posted
9 Jul 2020
Conditions
Adult Growth Hormone Deficiency · Growth Hormone Disorder

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 3

    REAL 2

    NCT02382939

    12 Feb 2015 to 4 Jan 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • somapacitanDrug
  • somatropinDrug

Arms2

  • Experimental

    somapacitan

  • Active comparator

    hGH (somatropin)

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Incidence of Adverse Events

    Time frame · Weeks 0 - 26

    Registry description

    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.

  2. Incidence of Injection Site Reactions

    Time frame · Weeks 0- 26

    Registry description

    Presented results are event (injection site reaction) rate per 100 patient years of exposure.

Secondary outcomes(2)

  1. Occurrence of Anti-NNC0195-0092 Antibodies

    Time frame · At week 0 (baseline), and at week 2, 4, 8, 16, 25 and 27

    Registry description

    Number of participants with anti-somapacitan (NNC0195-0092) antibodies are presented.

  2. Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores (Effectiveness,Convenience, and Global Satisfaction Scores)

    Time frame · Baseline (week 0), week 26

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Weeks 0 - 26

Incidence of Adverse Events

GroupValue (Events per 100 patient years)
Norditropin530.8
Somapacitan514.2
Primary outcomeNumber· Weeks 0- 26

Incidence of Injection Site Reactions

GroupValue (Events per 100 patient years)
Norditropin0
Somapacitan6.5
Secondary and other outcome results(2)
Secondary outcomeCount of participants· At week 0 (baseline), and at week 2, 4, 8, 16, 25 and 27

Occurrence of Anti-NNC0195-0092 Antibodies

GroupValue (Participants)
Somapacitan0
Secondary outcomeMean· Baseline (week 0), week 26

Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores (Effectiveness,Convenience, and Global Satisfaction Scores)

GroupValue (Score on a scale)Spread
Norditropin3.827.4
Somapacitan9.718.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
NorditropinParticipants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values: IGF-I SDS \> 3: dose reduction by 0.1 mg/day 2 \< IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 \< IGF-I SDS ≤ 2: No need of dose adjustment * 2 \< IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed.–2 / 3118 / 31
SomapacitanParticipants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values: IGF-I SDS \> 3: dose reduction by 1 mg 2 \< IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 \< IGF-I SDS ≤ 2: No need for dose adjustment * 2 \< IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.–4 / 6130 / 61

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2023

10 results

Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency.

Takahashi et al. 2023Pituitarycited by 12

PMID 36380045PMC9908671DOI 10.1007/s11102-022-01283-3PUB-36380045

CC BY10 results
Download PDFSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 79 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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