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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00787878
First received: November 7, 2008
Last updated: April 29, 2014
Last verified: April 2014

November 7, 2008
April 29, 2014
February 2009
January 2011   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: Index 5 years after end of GH treatment compared to controls ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00787878 on ClinicalTrials.gov Archive Site
Disposition index, glucose effectiveness and acute insulin response compared to controls [ Time Frame: 5 years after end of Norditropin treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

Blood samples

Non-Probability Sample

GH treated SGA and controls of non-treated SGA and AGA

  • Foetal Growth Problem
  • Small for Gestational Age
  • Drug: somatropin
    SGA previously treated with Norditropin®
    Other Name: GHLIQUID
  • Drug: No treatment given
    Untreated SGA
  • Drug: No treatment given
    AGA (Average gestational age)
  • A
    Intervention: Drug: somatropin
  • B
    Intervention: Drug: No treatment given
  • C
    Intervention: Drug: No treatment given
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00787878
GHLIQUID-1975
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP