E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Metabolic disease in which a person has high blood sugar because the body does not produce enough insulin |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012608 |
E.1.2 | Term | Diabetes mellitus insulin-dependent |
E.1.2 | System Organ Class | 100000004861 |
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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 assess the strength of the relationship between the extent of insulin absorption and tissue flow resistance (i.e., the resistance exerted by the tissue on the infused insulin solution) during prolonged use of an insulin infusion site. |
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E.2.2 | Secondary objectives of the trial |
To determine the histologic correlate of the increased tissue flow resistance in the tissue surrounding an insulin infusion cannula. & To ascertain the cause of the reduction in the extent of insulin absorption after prolonged infusion site use. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 18 to 64 years of age, both inclusive
- Type 1 diabetes treated with CSII
- Fasting C-peptide < 0.3 nmol/L
- HbA1c < 10%
- Signed informed consent prior to the participation in any study-related activities
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E.4 | Principal exclusion criteria |
- Severe acute and/or chronic diseases which the investigator or the acting physician feels would interfere with the trial or the safety of the subject
- Clinically overt diabetic complications
- Mental incapacity, unwillingness, or language barriers precluding adequate understanding or co-operation
- Uncontrolled hypertension
- Diseases of the skin which could interfere with the catheter and sensor application as judged by the investigator
- No superficial veins for catheter insertion as judged by the investigator
- Use of a medication that significantly impacts glucose metabolism (i.e. oral or topical steroids) except in the case of a stable state with a minimum duration of at least three months preceding the study as well as under the condition that the state remain stable for the duration of the study
- Pregnancy, breastfeeding, intention of becoming pregnant, or not using adequate contraception
- Any disease or condition which the investigator or the acting physician feels would interfere with the trial or the safety of the subject
- Blood donation within three months preceding the study
- Current enrollment or past participation in another investigational study ore signing of consent in this clinical study
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E.5 End points |
E.5.1 | Primary end point(s) |
AUCinsulin, area under the plasma insulin concentration curve |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
during a 75g oral glucose tolerance test (OGTT) per visit |
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E.5.2 | Secondary end point(s) |
- TFR, tissue flow resistance determined on each day during infusion site usage
- TINSmax, time to reach the maximum plasma insulin concentration during the 5-h OGTTs
- GLUmean3-5h, average plasma glucose concentration during the last 2 hours of the 5-h OGTTs
- AUCglucose, area under the plasma glucose concentration curve observed during the 5-h OGTTs
- TGLUmax, time to reach the maximum plasma glucose concentration during the 5-h OGTTs
- CLL, number of cells per tissue section
- CollF, number of collagen fibrils per tissue section
- InsF, number of insulin fibrils per tissue section
- number of iproteolytic enzymes (like insulin degrading enzymes) per tissue section
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
before/during the OGTT per visit |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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 |
same dosage of insulin once on the first day of infusion site use and twice after prolonged use |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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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Drop-outs will be replaced. The study is considered complete if 22 eligible patients complete the whole study |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |