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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

NCT ID: NCT02382939

Last Updated: 2020-07-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-12

Study Completion Date

2016-01-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Adult Growth Hormone Deficiency Growth Hormone Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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somapacitan

Group Type EXPERIMENTAL

somapacitan

Intervention Type DRUG

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.

hGH (somatropin)

Group Type ACTIVE_COMPARATOR

somatropin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Århus C, , Denmark

Site Status

Novo Nordisk Investigational Site

København Ø, , Denmark

Site Status

Novo Nordisk Investigational Site

Odense, , Denmark

Site Status

Novo Nordisk Investigational Site

Angers, , France

Site Status

Novo Nordisk Investigational Site

Brest, , France

Site Status

Novo Nordisk Investigational Site

Bron, , France

Site Status

Novo Nordisk Investigational Site

Dijon, , France

Site Status

Novo Nordisk Investigational Site

Saint-Herblain, , France

Site Status

Novo Nordisk Investigational Site

Aachen, , Germany

Site Status

Novo Nordisk Investigational Site

Berlin, , Germany

Site Status

Novo Nordisk Investigational Site

Frankfurt, , Germany

Site Status

Novo Nordisk Investigational Site

Bunkyo-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Itabashi-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Izumo, Shimane, , Japan

Site Status

Novo Nordisk Investigational Site

Kobe, Hyogo, , Japan

Site Status

Novo Nordisk Investigational Site

Kobe-shi, Hyogo, , Japan

Site Status

Novo Nordisk Investigational Site

Kyoto-shi Kyoto, , Japan

Site Status

Novo Nordisk Investigational Site

Okayama, Okayama, , Japan

Site Status

Novo Nordisk Investigational Site

Sagamihara-shi, Kanagawa, , Japan

Site Status

Novo Nordisk Investigational Site

Gothenburg, , Sweden

Site Status

Novo Nordisk Investigational Site

Lund, , Sweden

Site Status

Novo Nordisk Investigational Site

Stockholm, , Sweden

Site Status

Novo Nordisk Investigational Site

Birmingham, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Exeter, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Leeds, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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Denmark France Germany Japan Sweden United Kingdom

References

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Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.

Reference Type DERIVED
PMID: 36380045 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2014-000290-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1152-3664

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-152850

Identifier Type: OTHER

Identifier Source: secondary_id

NN8640-4043

Identifier Type: -

Identifier Source: org_study_id

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