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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00787878

Enrollment

153

Registered

2008-11-10

Start date

2009-02-28

Completion date

2011-01-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foetal Growth Problem, Small for Gestational Age

Brief 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.

Interventions

DRUGsomatropin

SGA previously treated with Norditropin®

DRUGNo treatment given

Untreated SGA

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to 24 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Insulin sensitivity	Index 5 years after end of GH treatment compared to controls

Secondary

Measure	Time frame
Disposition index, glucose effectiveness and acute insulin response compared to controls	5 years after end of Norditropin treatment

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026