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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00787878

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
Small for Gestational Age (SGA)	Drug: No treatment given

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Observational
Study Design:	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.

Further study details as provided by Novo Nordisk:

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

Biospecimen Description:

Blood samples

Estimated Enrollment:	150
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: No treatment given SGA previously treated with Norditropin®
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

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

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

Netherlands

Rotterdam, Netherlands, 3015 GJ

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Lene Finnerup Nielsen, MSC Odont

Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	GHLIQUID-1975, EudraCT No: 2007-004986-16
Study First Received:	November 7, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00787878
Health Authority:	Netherlands: Ethics Committee

ClinicalTrials.gov processed this record on January 16, 2009