Diabetes, Diabetes Mellitus, Type 2, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.
Interventions
DRUGinsulin degludec/liraglutide
Subject will receive a single injection (s.c.) of IDegLira B5
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female volunteers * Body mass index (BMI) between 18.5 and 27.0 kg/m\^2 (both inclusive) * Body weight between 60 and 90 kg (both inclusive)
Exclusion criteria
* Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner * History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders * Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial * Drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma liraglutide concentration time curve after single dose | Assessed from 0-72 hours |
| Maximum observed plasma liraglutide concentration after single dose | Assessed from 0-72 hours |
| Area under the serum IDeg concentration time curve after single dose | Assessed from 0 to 120 hours |
| Maximum observed serum IDeg concentration after single dose | Assessed from 0-120 hours |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum IDeg concentration | Assessed from 0-120 hours |
| Area under the plasma liraglutide concentration time curve after single dose | Assessed from 0-72 hours |
| Terminal elimination half-life for IDeg after single dose | Assessed from 0-120 hours |
| Time to maximum plasma liraglutide concentration after single dose | Assessed from 0-72 hours |
| Terminal elimination half-life of liraglutide after single dose | Assessed from 0-72 hours |
| Area under the serum IDeg concentration time curve after single dose | Assessed from 0-120 hours |
Countries
Germany
Outcome results
None listed