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
1 other identifier
observational
153
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2008
CompletedFirst Posted
Study publicly available on registry
November 10, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJanuary 18, 2017
January 1, 2017
1.9 years
November 7, 2008
January 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Insulin sensitivity
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
5 years after end of Norditropin treatment
Study Arms (3)
A
B
C
Interventions
Eligibility Criteria
GH treated SGA and controls of non-treated SGA and AGA
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Rotterdam, 3015 CN, Netherlands
Related 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 short SGA controls. J Clin Endocrinol Metab. 2007 Jan;92(1):160-5. doi: 10.1210/jc.2006-1073. Epub 2006 Oct 24.
PMID: 17062774RESULT
Related Links
Biospecimen
Blood samples
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2008
First Posted
November 10, 2008
Study Start
February 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 18, 2017
Record last verified: 2017-01