Skip to main content
OpenTrials
Completed

NCT Number: NCT00787878

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Foetal Growth Problem Small for Gestational Age

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Rotterdam, 3015 CN, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

SGA previously treated with Norditropin®

Other names: GHLIQUID

No treatment given

Drug

Untreated SGA

Primary outcomes

  1. Insulin sensitivity

    Time frame: Index 5 years after end of GH treatment compared to controls

Secondary outcomes

  1. Disposition index, glucose effectiveness and acute insulin response compared to controls

    Time frame: 5 years after end of Norditropin treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 10, 2008
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.