NCT02382939|CompletedPhase 3Results

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

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

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN8640-40432014-000290-39U1111-1152-3664JapicCTI-152850

Study Type

interventional

Target

Locations

6 countries

Sites

Timeline

RegisteredMar 2015

StartedFeb 2015

CompletionJan 2016

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Feb 2015

Shorter than P25 for phase_3

Geographic Reach

6 countries

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

February 10, 2015

Completed

2 days until next milestone

Study Start

First participant enrolled

February 12, 2015

Completed

25 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2016

Completed

4.5 years until next milestone

Results Posted

Study results publicly available

June 16, 2020

Completed

Last Updated

July 9, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

February 10, 2015

Results QC Date

May 1, 2020

Last Update Submit

June 23, 2020

Conditions

Adult Growth Hormone Deficiency Growth Hormone Disorder

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (2)

Occurrence of Anti-NNC0195-0092 Antibodies
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)
Baseline (week 0), week 26

Study Arms (2)

somapacitan

EXPERIMENTAL

Drug: somapacitan

hGH (somatropin)

ACTIVE COMPARATOR

Drug: somatropin

Interventions

somapacitanDRUG

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.

somapacitan

somatropinDRUG

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.

hGH (somatropin)

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.