A double-blind, comparator-controlled, randomised, three-period crossover euglycemic clamp trial to evaluate pharmacokinetics of single doses of BC222 insulin lispro in healthy Japanese subjects

• Conditions: Diabetes mellitus; MedDRA version: 18.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-004829-13-DE
• Lead Sponsor: Adocia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-07
• Last Update Posted: 11 January 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
2. To qualify as a subject of Japanese origin (first-generation Japanese), the subject, the subject’s biological parents, and all of the subject’s biological grandparents are of exclusive Japanese descent and have been born in Japan
3. Age = 20 and = 64 years, both inclusive.
4. BMI between 18.5 and 25.0 kg·m-2, both inclusive.
5. FPG = 5.6 mmol/L (100 mg/dL).
6. Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject.
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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known or suspected hypersensitivity to trial product(s) or related products.
2. Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
3. Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
4. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the pharmacokinetic profiles of single doses of BC222 insulin lispro administered subcutaneously in healthy Japanese subjects;Secondary Objective: - To evaluate the pharmacodynamic profiles of single doses of BC222 insulin lispro administered subcutaneously in healthy Japanese subjects<br>- To assess the safety and tolerability of single doses of BC222 insulin lispro administered subcutaneously in healthy Japanese subjects<br>;Primary end point(s): This is not applicable, as this is an explorative study, where no primary and secondary endpoint, respectively, has been defined.<br>;Timepoint(s) of evaluation of this end point: n/a

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): This is not applicable, as this is an explorative study, where no primary and secondary endpoint, respectively, has been defined.;Timepoint(s) of evaluation of this end point: n/a