A controlled, randomized, open-label parallel study to explore the impact of treatment with insulin glulisine on lipoatrophy in children, adolescents and young adults with Type 1 Diabetes.

Phase 1

Conditions: Type 1 Diabetes mellitus and Lipoatrophy
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2015-004536-35-DE

Lead Sponsor: Kinder- und Jugendkrankenhaus AUF DER BULT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 24

Inclusion Criteria

•Patients with type 1 diabetes and documented lipoatrophy at injection sites on CSII treatment
•Age between 6 and 40 years (both inclusive)
•Signed informed consent form from patients or from parents/their guardians if children/youths <18 years
•Patients must be willing to undergo all study procedures

Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with previous use of insulin glulisine
•Patients requiring corticosteroids as treatment medication
•Patients suffering from severe chronic disease other than T1D or genetic disorder (i.e. Down syndrome etc.)
•Pregnancy
•Patients participating in other device or drug studies

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether a zinc-free insulin is an effective treatment option for lipoatrophy in patients with T1D and insulin pump (CSII, continuous subcutaneous insulin infusion) therapy;Secondary Objective: not applicable;Primary end point(s): - Comparison of the MRI findings, particularly the increase of the thickness of the subcutaneous fat layer between cutis and the muscle fascia to assess the effect of introducing a zinc-free insulin in the treatment of T1D patients with lipoatrophy at 6 months between both arms;Timepoint(s) of evaluation of this end point: Standard statistical procedures will be performed after the study is completed.

Secondary Outcome Measures