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

Novo Nordisk A/S153 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

153

Conditions

Foetal Growth Problem Small for Gestational Age

Interventions

somatropinDRUG

SGA previously treated with Norditropin®

No treatment givenDRUG

Untreated SGA

No treatment givenDRUG

AGA (Average gestational age)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 24 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Insulin sensitivity

Time frame: Index 5 years after end of GH treatment compared to controls

Secondary Outcomes

Disposition index, glucose effectiveness and acute insulin response compared to controls

Time frame: 5 years after end of Norditropin treatment

Data from ClinicalTrials.gov

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