E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
|
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 | 16.0 |
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 |
|
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 |
The overall goal of the study is to assess the resistance exerted by the tissue upon the insulin solution entering the tissue (hydraulic tissue resistance) at the administration site and determine its relationship to the ability of the tissue to absorb the administered insulin |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 to 65 years of age, both inclusive
Type 1 diabetes treated with continuous subcutaneous
insulin infusion for >12 months
HbA1c < 10%
Fasting C-peptide < 0.3nmol/L
Signed informed consent prior to the participation in
any study-related activities
|
|
E.4 | Principal exclusion criteria |
Severe acute diseases
Clinically overt diabetic complications
Mental incapacity, unwillingness, or language barriers
precluding adequate understanding or co-operation
Taking any vasoactive substances or anticoagulatory
medication
Symptomatic coronary artery disease (e.g. history of
myocardial infarction, history of acute coronary
syndrome, history of therapeutic coronary intervention,
history of coronary bypass or stenting procedure,
stable or unstable angina, positive stress test or
catheterization with coronary blockages >50%),
congestive heart failure, or a history of a cerebro-
vascular event
Uncontrolled hypertension
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
No superficial veins for catheter insertion as judged by
the investigator
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
Concurrent participation in another study
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
GLUAOGTT, average plasma glucose concentration |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
during a 75g oral glucose tolerance test (OGTT) per visit |
|
E.5.2 | Secondary end point(s) |
TR, hydraulic tissue resistance
GLUmax, maximum plasma glucose concentration
GLUEXmax, maximum plasma glucose excursion
AUCGLU, area under the plasma glucose concentration curve
INSmax, maximum plasma concentration of rapid-acting insulin
AUCINS, area under the plasma insulin concentration curve
TGLUmax, time to reach the maximum plasma glucose concentration
TINSmax, time to reach the maximum plasma insulin concentration |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
before/during the OGTT bper visit |
|
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 the insulin once on the first day of infusion site use and once after prolonged use |
|
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
|
Drop-outs will be replaced. The study is considered complete if 10 eligible patients complete the whole study |
|
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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |