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 | 17.1 |
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 asses the duration of glucagon’s waning effect on the hepatic glucose production in type 1 diabetes patients |
|
E.2.2 | Secondary objectives of the trial |
To asses the duration of glucagon’s waning effect on the blood glucose concentration in type 1 diabetes patients |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Type 1 diabetes treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for 12 months
Male or female aged 18-65 years (both inclusive)
HbA1c < 10%
Informed consent obtained after being advised of the nature of the study |
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E.4 | Principal exclusion criteria |
Pregnancy, breast-feeding, intention of becoming pregnant, or not using adequate contraception
Any disease or condition which would interfere with the subject's safety
Skin pathology or condition prohibiting needle insertion/glucagon administration as judged by the investigator
Severe acute diseases
Current participation in another clinical study
Uncontrolled hypertension
Clinically overt diabetic complications
Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
Taking any vasoactive substances or anticoagulatory medication
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 3 months preceeding the study as well as under the condition that the state remain stable for the duration of the study
Symptomatic coronary artery disease
Blood donation within 3 months preceeding the study
|
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E.5 End points |
E.5.1 | Primary end point(s) |
ΔAUCHGP, percentage reduction in the area under the hepatic glucose production rate curve |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Observed for 120 minutes following the second glucagon administration compared to that observed for 120 minutes following the first glucagon administration |
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E.5.2 | Secondary end point(s) |
ΔHGPMAX, percentage reduction in the maximum hepatic glucose production rate
ΔAUCPG, percentage reduction in the area under the plasma glucose concentration curve
ΔPGMAX, percentage reduction in the maximum plasma glucose concentration
AUCPGL, area under the plasma glucagon concentration curve |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Observed following the second glucagon administration compared to that observed following the first glucagon administration
Observed for 120 minutes following the second glucagon administration compared to that observed for 120 minutes following the first glucagon administration
Observed for 120 minutes following each glucagon administration |
|
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 | 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 | Yes |
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 |
Two identical dosages of glucagon once separated by 4, twice by 8, and once by 12 hours |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 5 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 |