Current partner codePEPTIDESDE
NCT02382939·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

92

Locations

28

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Mar 9, 2015

  2. Study start

    Feb 12, 2015

  3. Primary completion

    Jan 4, 2016

  4. Study completion

    Jan 4, 2016

  5. Results posted

    Jun 16, 2020

  6. Registry updated

    Jul 9, 2020

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
79 Years
Sex
ALL
Healthy volunteers
No

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 locations

28 registered sites.

Denmark · France · Germany · Japan · Sweden · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

Novo Nordisk Investigational Site

Århus C, Denmark

Novo Nordisk Investigational Site

København Ø, Denmark

Novo Nordisk Investigational Site

Odense, Denmark

Novo Nordisk Investigational Site

Angers, France

Novo Nordisk Investigational Site

Brest, France

Novo Nordisk Investigational Site

Bron, France

Novo Nordisk Investigational Site

Dijon, France

Novo Nordisk Investigational Site

Saint-Herblain, France

Novo Nordisk Investigational Site

Aachen, Germany

Novo Nordisk Investigational Site

Berlin, Germany

Novo Nordisk Investigational Site

Frankfurt, Germany

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, Japan

Novo Nordisk Investigational Site

Gothenburg, Sweden

Novo Nordisk Investigational Site

Lund, Sweden

Novo Nordisk Investigational Site

Stockholm, Sweden

Novo Nordisk Investigational Site

Birmingham, United Kingdom

Novo Nordisk Investigational Site

Exeter, United Kingdom

Related trials

More studies on Somapacitan.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.