Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects

Small for Gestational Age Clinical Trial

Official title:

Comparison of Safety in Small for Gestational Age (SGA) Subjects Treated With Norditropin® (Somatropin) 5 Years Ago With Untreated SGA Subjects and With Normal Average for Gestational Age (AGA) Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787878
• Other study ID #: GHLIQUID-1975
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2008
• Last updated: January 17, 2017
• Start date: February 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is conducted in Europe. The primary aim of this observational study is to compare the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin® with untreated small for gestational age (SGA) subjects and with average for gestational age (AGA) subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Norditropin® treated small for gestational age (SGA) group: Treated with Norditropin® for at least three years in the IUGR-1 or IUGR-2 trials

• Untreated small for gestational age (SGA) group: Birth length and/or weight less than -2 SDS for gestational age

• Average gestational age (AGA) group: Birth length and/or weight larger than -2 SDS for gestational age

Exclusion Criteria:

• Growth hormone deficiency defined as a peak growth hormone (GH) less than 20 mU/l

• Insulin like growth (IGF)-1 level less than -2 SDS

• Receipt of any investigational drug within four weeks prior to the trial

Related Conditions & MeSH terms

• Foetal Growth Problem
• Small for Gestational Age

Intervention

Drug:
• somatropin
SGA previously treated with Norditropin®
• No treatment given
Untreated SGA
• No treatment given
AGA (Average gestational age)

Locations

Country	Name	City	State
Netherlands	Novo Nordisk Investigational Site	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

van Dijk M, Bannink EM, van Pareren YK, Mulder PG, Hokken-Koelega AC. Risk factors for diabetes mellitus type 2 and metabolic syndrome are comparable for previously growth hormone-treated young adults born small for gestational age (sga) and untreated sho — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		Index 5 years after end of GH treatment compared to controls
Secondary	Disposition index, glucose effectiveness and acute insulin response compared to controls		5 years after end of Norditropin treatment

External Links

•   Clinical Trials at Novo Nordisk