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 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067584 |
E.1.2 | Term | Type 1 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 compare, in type 1 diabetes patients, the early insulin exposure after administration of a 0.2 U·kg BW-1 single dose BC222 human insulin and Huminsulin® Normal during euglycaemic clamps. |
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E.2.2 | Secondary objectives of the trial |
To compare the pharmacokinetic (PK) profile after administration of a 0.2 U·kg BW-1 single dose BC222 human insulin and Humalog®.
To compare the glucodynamic actions in response to a 0.2 U·kg BW-1 single dose BC222 human insulin, Huminsulin® Normal and Humalog.
To assess and compare the safety and tolerability of BC222 human insulin, Huminsulin® Normal and Humalog. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Male subjects with type 1 diabetes mellitus.
2. Age between 18 and 64 years, both inclusive.
3. Body mass index (BMI) between 18.5 and 28.0 kg BW·m-2, both inclusive.
4. HbA1c ≤ 9.0 %. |
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E.4 | Principal exclusion criteria |
1. Diabetes mellitus type 2.
2. Previous participation in this trial. Participation is defined as being randomised.
3. The receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial.
4. Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator considering the underlying disease.
5. History of or presence of cancer (except basal cell skin cancer or squamous cell skin cancer), or any clinically significant cardiovascular (with the exception of treated hypertension), respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), hematological (bleeding disorder), dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the Investigator.
6. Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
7. Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial) and/or resting supine heart rate outside the range 50-90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives.
8. Clinically significant abnormal ECG at screening, as judged by the Investigator.
9. Proliferative retinopathy or maculopathy, as judged by the Investigator based on a recent (< 1.5 years) ophthalmologic examination.
10. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months.
11. Clinically significant diabetic neuropathy, in |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Cmax(Ins/Lisp)
AUCIns/Lisp(0-30min)
AUCIns/Lisp(0-1h)
AUCIns/Lisp(0-2h)
AUCIns/Lisp(0-4h)
AUCIns/Lisp(0-6h)
AUCIns/Lisp(0-8h)
AUCIns/Lisp(0-10h)
AUCIns/Lisp(0-last)
AUCIns/Lisp(0-inf)
AUCIns/Lisp(2h-10h)
AUCIns/Lisp(3h-10h)
AUCIns/Lisp(4h-10h)
AUCIns/Lisp(6h-10h)
tmax (InsLisp)
t1/2 (Ins/Lisp)
AUCIns/Lisp(0-30min)·AUCIns/Lisp(0-10h)-1
AUCIns/Lisp(0-1h)·AUCIns/Lisp(0-10h)-1
AUCIns/Lisp(0-2h)·AUCIns/Lisp(0-10h)-1
AUCIns/Lisp(0-4h)·AUCIns/Lisp(0-10h)-1
AUCIns/Lisp(0-6h)·AUCIns/Lisp(0-10h)-1
AUCIns/Lisp(0-8h)·AUCIns/Lisp(0-10h)-1
AUCIns/Lisp(2-10h)·AUCIns/Lisp(0-10h) 1
AUCIns/Lisp(3-10h)·AUCIns/Lisp(0-10h) 1
AUCIns/Lisp(4-10h)·AUCIns/Lisp(0-10h) 1
AUCIns/Lisp(6-10h)·AUCIns/Lisp(0-10h) 1
Early t[0.5max(Ins/Lisp)]
Late t[0.5max(Ins/Lisp)]
tonset of appearance (Ins/Lisp)
Early t[0.1max(Ins/Lisp)] |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
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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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 | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |