Status:
COMPLETED
Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Foetal Growth Problem
Small for Gestational Age
Eligibility:
All Genders
18-24 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00787878
Start Date
February 1 2009
End Date
January 1 2011
Last Update
January 18 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3015 CN