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

PHASE3CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

February 12, 2015

Primary Completion Date

January 4, 2016

Study Completion Date

January 4, 2016

Conditions
Adult Growth Hormone DeficiencyGrowth Hormone Disorder
Interventions
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.

Trial Locations (28)

2100

Novo Nordisk Investigational Site, København Ø

5000

Novo Nordisk Investigational Site, Odense

8000

Novo Nordisk Investigational Site, Århus C

10117

Novo Nordisk Investigational Site, Berlin

21079

Novo Nordisk Investigational Site, Dijon

29609

Novo Nordisk Investigational Site, Brest

44800

Novo Nordisk Investigational Site, Saint-Herblain

49000

Novo Nordisk Investigational Site, Angers

52074

Novo Nordisk Investigational Site, Aachen

60596

Novo Nordisk Investigational Site, Frankfurt

69677

Novo Nordisk Investigational Site, Bron

113-8603

Novo Nordisk Investigational Site, Bunkyo-ku, Tokyo

173-8606

Novo Nordisk Investigational Site, Itabashi-ku, Tokyo

691-8501

Novo Nordisk Investigational Site, Izumo, Shimane

650-0017

Novo Nordisk Investigational Site, Kobe, Hyogo

657-0846

Novo Nordisk Investigational Site, Kobe-shi, Hyogo

612-8555

Novo Nordisk Investigational Site, Kyoto-shi Kyoto

700-8558

Novo Nordisk Investigational Site, Okayama, Okayama

252-0375

Novo Nordisk Investigational Site, Sagamihara-shi, Kanagawa

413 45

Novo Nordisk Investigational Site, Gothenburg

221 85

Novo Nordisk Investigational Site, Lund

171 76

Novo Nordisk Investigational Site, Stockholm

B15 2TH

Novo Nordisk Investigational Site, Birmingham

EX2 5DW

Novo Nordisk Investigational Site, Exeter

LS9 7TF

Novo Nordisk Investigational Site, Leeds

EC1A 7BE

Novo Nordisk Investigational Site, London

SE5 9RS

Novo Nordisk Investigational Site, London

M20 4BX

Novo Nordisk Investigational Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY