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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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