Diabetes mellitus type 1 MedDRA version: 17.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: BC222 human insulin
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Concentration unit: IU/ml international unit(s)/millili
Sponsors
Adocia
Eligibility
Sex/Gender
Male
Inclusion criteria
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 %. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): AUCIns(0-1h) ;Timepoint(s) of evaluation of this end point: Data base release | — |
Secondary
| Measure | Time frame |
|---|---|
| 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)] ;Timepoint(s) of evaluation of this end point: Data base release | — |
Countries
Germany
Contacts
Public ContactDeputy General Manager
Adocia
Outcome results
None listed