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

Novo Nordisk

Status: Completed

Conditions: Small for Gestational Age; Foetal Growth Problem

Treatments: Drug: No treatment given; Drug: somatropin

Study type: Observational

Funder types: Industry

Identifiers

NCT00787878

GHLIQUID-1975

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

153 participants in 3 patient groups

A

Treatment:

Drug: somatropin

B

Treatment:

Drug: No treatment given

Drug: No treatment given

C

Treatment:

Drug: No treatment given

Drug: No treatment given