Type 1 Diabetes mellitus and Lipoatrophy
Conditions
Interventions
Trade Name: Apidra®
Product Name: Glulisine
Product Code: not applicable
Pharmaceutical Form: Injection
INN or Proposed INN: Apidra
CAS Number: 207748-29-6
Other descriptive name: INSULIN GLULISINE
Co
Sponsors
Kinder- und Jugendkrankenhaus AUF DER BULT
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary 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 between 6 months and 12 months in the control group - Comparison of the MRI findings, particularly the increase of the thickness of the subcutaneous fat layer between cutis and the muscle fascia between baseline and 12 months in both arms - Comparison of the ultrasound findings, particularly the increase of the thickness of the subcutaneous fat layer between cutis and the muscle fascia at 6 months between both arms - Comparison of the USG findings, particularly the increase of the thickness of the subcutaneous fat layer between cutis and the muscle fascia between 6 and 12 months in the control group - Comparison of the USG findings, particularly the increase of the thickness of the subcutaneous fat layer between cutis and the muscle fascia between baseline and 12 months in both arms - Comparison of dermatological findings at 6 months between both arms - Comparison of dermatological findings between 6 and 12 months in the control group - Occurrence of new lipoatrophic areas in both arms at 6 and 12 months - Long-term follow-up of glycemic control (HbA1c) and insulin requirements (total daily insulin units per kg body weight) at 6 and 12 months compared to baseline - Comparison of laboratory parameters (insulin antibodies, total IgE, specific insulin-IgE) between baseline, 6 months and 12 months - Side-effects of treatment with other insulins and insulin glulisine such as o severe hypoglycemia o DKA o Catheter occlusion o SAEse enter information in English and add any other language that is applicable;Timepoint(s) of evaluation of this end point: Standard statistical procedures will be performed after the study is completed. | — |
Countries
Germany
Contacts
Public ContactBärbel Aschemeier
Kinder- und Jugendkrankenhaus AUF DER BULT
Outcome results
None listed