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

• Conditions: Patients with type 1 diabetes; MedDRA version: 14.1Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-002210-37-DK
• Lead Sponsor: niversity of Aarhus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-16
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Informed consent obtained before any trial-related activities.
2.Diagnosis of diabetes mellitus according to WHO criteria; history and clinical course consistent with type 1 diabetes.
3.Diagnosed with diabetes for more than 6 years and using continuous subcutaneous insulin infusion (CSII) at least 6 months at time of inclusion.
4.Total daily insulin dose between 0.4 and 1.4 units/kg (both values included)
5.HbA1c between 6% and 9% (both values included).
6.Age = 18 years.
7.BMI between 18.5 and 28 kg /m2 (including both values).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known or suspected allergy to trial product(s) or related products.
2.Recurrent major hypoglycaemic episodes.
3.Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV
4.Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting
5.Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase > 2 x upper reference limit of the local laboratory.
6.Kidneys: Impaired renal function corresponding to serum-creatinin > 150 µmol/l according to the local laboratory.
7.Any disease judged by the investigator to affect the trial.
8.Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures – adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective is to describe the interaction of equal doses of NPH insulin, insulin detemir and insulin glargine on IGFBP-1 production as well as immunoreactive and bioactive IGF-I after once-daily injection on three separate visits in type 1 diabetic subjects. ;Secondary Objective: Secondary objectives of the trial is safety evaluation.;Primary end point(s): IGF-I and IGFBP-1;Timepoint(s) of evaluation of this end point: 18:00-10:00 of next day (16 hours)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): IGFBP-2 and IGFBP-3, growth hormone, glucose and insulin concentration;Timepoint(s) of evaluation of this end point: 18:00-10:00 of next day (16 hours)