A double-blinded, randomised, four -period crossover euglycemic clamp trial investigating the dose-response and dose-exposure relationship of BC222 insulin lispro in three different doses in subjects with type 1 Diabetes
- Conditions
- Diabetes mellitus type 1MedDRA version: 16.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-000949-77-DE
- Lead Sponsor
- Adocia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
•Male subjects with type 1 diabetes mellitus
•age between 18 and 64 years
•Body mass index (BMI) between 18.5 and 28.0 kg/m2
•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 38
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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), haematological (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 (< 1.5years) 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the dose-response and the dose-exposure relationships of BC222 insulin lispro;Secondary Objective: To compare the pharmacokinetics and the glucodynamic action of BC222 insulin lispro at 0.2 IU/kg with Humalog® at 0.2 IU/kg.<br>To assess the safety and tolerability of BC222 insulin lispro and Humalog® .<br>;Primary end point(s): AUCGIR(l0-last)<br>GIRmax<br>AUCLisp(0-last) <br>Cmax(Lisp) ;Timepoint(s) of evaluation of this end point: Data base release
- Secondary Outcome Measures
Name Time Method Secondary end point(s): AUCLisp(0 15min)<br>AUCLisp(0 30min)<br>AUCLisp(0 1h)<br>AUCLisp(0-2h)<br>AUCLisp(0-4h)<br>AUCLisp(0-8h)<br>AUCLisp(0-12h)<br>AUCLisp(0-inf)<br>t1/2Lisp<br>Terminal elimination rate constant of total insulin <br>AUCLisp(0 15min)•AUCLisp(0-12h) 1<br>AUCLisp(0-30min)•AUCLisp(0-12h) 1<br>AUCLisp(0 1h)•AUCLisp(0-12h) 1<br>AUCLisp(0-2h)•AUCLisp(0-12h) 1<br>AUCLisp(0-4h)•AUCLisp(0-12h) 1<br>AUCLisp(0-8h)•AUCLisp(0-12h) 1<br>tmax(Lisp)<br>Early t[0.5max(/Lisp)]<br>Late t[0.5max(Lisp)]<br>tonset of appearance (Lisp)<br>Early t[0.1max(Lisp)]<br>texposure(Lisp)<br><br>;Timepoint(s) of evaluation of this end point: Data base release