A double-blinded, randomised, three-period crossover euglycaemic clamp trial investigating the pharmacokinetics, glucodynamics and safety of BC222 human insulin, human insulin (Huminsulin® Normal) and insulin lispro (Humalog®) in subjects with type 1 diabetes

Active, not recruiting

• Conditions: Diabetes mellitus type 1; MedDRA version: 17.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-001432-11-DE
• Lead Sponsor: Adocia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-26
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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®.<br>To compare the glucodynamic actions in response to a 0.2 U·kg BW-1 single dose BC222 human insulin, Huminsulin® Normal and Humalog?.<br><br>To assess and compare the safety and tolerability of BC222 human insulin, Huminsulin® Normal and Humalog.;Primary end point(s): AUCIns(0-1h)<br>;Timepoint(s) of evaluation of this end point: Data base release

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Cmax(Ins/Lisp) <br>AUCIns/Lisp(0-30min) <br>AUCIns/Lisp(0-1h) <br>AUCIns/Lisp(0-2h) <br>AUCIns/Lisp(0-4h) <br>AUCIns/Lisp(0-6h)<br>AUCIns/Lisp(0-8h) <br>AUCIns/Lisp(0-10h) <br>AUCIns/Lisp(0-last) <br>AUCIns/Lisp(0-inf) <br>AUCIns/Lisp(2h-10h)<br>AUCIns/Lisp(3h-10h)<br>AUCIns/Lisp(4h-10h)<br>AUCIns/Lisp(6h-10h)<br> tmax (InsLisp) <br>t1/2 (Ins/Lisp) <br>AUCIns/Lisp(0-30min)·AUCIns/Lisp(0-10h)-1 <br>AUCIns/Lisp(0-1h)·AUCIns/Lisp(0-10h)-1 <br>AUCIns/Lisp(0-2h)·AUCIns/Lisp(0-10h)-1<br>AUCIns/Lisp(0-4h)·AUCIns/Lisp(0-10h)-1 <br>AUCIns/Lisp(0-6h)·AUCIns/Lisp(0-10h)-1<br>AUCIns/Lisp(0-8h)·AUCIns/Lisp(0-10h)-1 <br>AUCIns/Lisp(2-10h)·AUCIns/Lisp(0-10h) 1<br>AUCIns/Lisp(3-10h)·AUCIns/Lisp(0-10h) 1<br>AUCIns/Lisp(4-10h)·AUCIns/Lisp(0-10h) 1<br>AUCIns/Lisp(6-10h)·AUCIns/Lisp(0-10h) 1<br>Early t[0.5max(Ins/Lisp)] <br>Late t[0.5max(Ins/Lisp)] <br>tonset of appearance (Ins/Lisp) <br>Early t[0.1max(Ins/Lisp)] ;Timepoint(s) of evaluation of this end point: Data base release