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MGF Igf-1-ec

IGF-1Ec, IGF-1Eb, Mechano-Growth Factor

Quick Stats
Studies 62
Trials 100
Completed PHASE3 INTERVENTIONAL NCT01461616

Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on GH-IGF-IGFBP Axis

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The objective is to describe the interaction of equal doses of NPH insulin (Neutral Protamine Hagedorn), insulin Detemir and insulin glargine on IGFBP-1 (Insulin-like Growth Factor Binding Protein-1) production as well as immunoreactive and bioactive IGF-I (Insulin-like Growth Factor-I) after once-daily injection on three separate visits in type 1 diabetic subjects.

Detailed Description

Because of the importance of receptors activation and potential effects on the IGF system, a head-to-head comparison of the eventual differential impact of intermediate-acting human insulin (NPH), insulin detemir and insulin glargine on the growth hormone-insulin-like growth factor-insulin-like growth factor binding protein (GH-IGF-IGFBP) axis is relevant to be conducted for the safety assurance of insulin analogues. Therefore, this study aims to investigate whether the serum insulin profile obtained by once-daily injection of long-acting insulin analog, insulin detemir or insulin glargine, has a different impact on IGFBPs production and IGF-I concentrations (total IGF-I) bioactivity and tissue-availability as compared to that seen during treatment with intermediate-acting human insulin, NPH insulin.

Interventions

Name: NPH
Type: DRUG
Description: equal doses of NPH insulin, insulin Detemir and insulin glargine injection
Name: Detemir
Type: DRUG
Description: equal doses of NPH insulin, insulin Detemir and insulin glargine injection
Name: Glargine
Type: DRUG
Description: equal doses of NPH insulin, insulin Detemir and insulin glargine injection

Primary Outcomes

Measure: IGF-I(ng/ml)
TimeFrame: 16 hours (from 18:00 to 10:00 next day)
Description: Hourly samples will be taken from 18:00 to 10:00 next day.
Measure: IGFBP-1(ng/ml)
TimeFrame: 16 hours (from 18:00 to 10:00 next day)
Description: Hourly samples will be taken from 18:00 to 10:00 next day.
Measure: IGFBP-2(ng/ml)
TimeFrame: 16 hours (from 18:00 to 10:00 next day)
Description: Hourly samples will be taken from 18:00 to 10:00 next day.
Measure: IGFBP-3(ng/ml)
TimeFrame: 16 hours (from 18:00 to 10:00 next day)
Description: Hourly samples will be taken from 18:00 to 10:00 next day.
Measure: Growth Hormone(ng/ml)
TimeFrame: 16 hours (from 18:00 to 10:00 next day)
Description: Hourly samples will be taken from 18:00 to 10:00 next day.

Trial Information

NCT ID

NCT01461616

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

University of Aarhus

Last Updated

December 15, 2025