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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
  Purpose

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.


Condition Intervention
Foetal Growth Problem
Small for Gestational Age
Drug: somatropin
Drug: No treatment given

Study Type: Observational
Study Design: Observational Model: Cohort
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Index 5 years after end of GH treatment compared to controls ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Blood samples


Enrollment: 153
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: somatropin
SGA previously treated with Norditropin®
Other Name: GHLIQUID
B Drug: No treatment given
Untreated SGA
C Drug: No treatment given
AGA (Average gestational age)

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787878

Locations
Netherlands
Rotterdam, Netherlands, 3015 GJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00787878     History of Changes
Other Study ID Numbers: GHLIQUID-1975
Study First Received: November 7, 2008
Last Updated: April 29, 2014
Health Authority: Netherlands: Ethics Committee

ClinicalTrials.gov processed this record on November 23, 2014