Long Term Metabolic Safety of Norditropin® Treatment of S... | NCT00787878

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

NCT00787878

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 18, 2017Estimated

Enrollment

153Actual

Phase

Not provided

Conditions

Foetal Growth Problem
Small for Gestational Age

Interventions

somatropin
No treatment given
No treatment given

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Nov 7, 2008

First Submission Date that Met QC Criteria

Nov 7, 2008

First Posted Date

Nov 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

153Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Drug: somatropin
B			Drug: No treatment given
C			Drug: No treatment given

Interventions

Name	Type	Description	Arm Group Labels	Other Names
somatropin	Drug	SGA previously treated with Norditropin®	A	GHLIQUID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin sensitivity		Index 5 years after end of GH treatment compared to controls

Secondary Outcomes

Measure	Description	Time Frame
Disposition index, glucose effectiveness and acute insulin response compared to controls		5 years after end of Norditropin treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

24 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Rotterdam		3015 CN	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17062774	Result	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.

ID	Term
D013006	Growth Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones