A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Adult Growth Hormone Deficiency

Growth Hormone Disorder

Treatments

Drug: Norditropin NordiFlex®

Drug: somapacitan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01706783

U1111-1125-7331 (Other Identifier)

NN8640-3947

2011-005484-24 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).

Enrollment

35 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment of adults with GHD
Stable human growth hormone (hGH) replacement therapy for at least 3 months

Exclusion criteria

Participation in another clinical trial within 3 months or receipt of any investigational medicinal product within 3 months prior to randomisation
Active malignant disease or malignant disease within the last 5 years with exception of fully treated local basal cell carcinoma or carcinoma in situ of cervix
Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
Heart insufficiency, New York Heart Association (NYHA) class above 2
Adults with GHD with poorly controlled diabetes mellitus with a glycosylated haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment
Stable pituitary replacement therapy for less than 3 months