E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 Diabetes mellitus and Lipoatrophy |
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E.1.1.1 | Medical condition in easily understood language |
Insulin- dependent autoimmune Diabetes and loss of fat tissue as a result of subcutaneous injections of insulin in the treatment of diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Standard statistical procedures will be performed after the study is completed. |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Standard statistical procedures will be performed after the study is completed. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study will be the Last Visit last Patient (anticipated for October 2017)
The primary analysis will be conducted following the intention-to-treat (ITT) principle including all randomized patients.
13.Nov.2017: The study was Extended by 18 months. The new end of study will anticipated for August 2019. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |