Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
The main purpose of the trial is to compare the bioavailability (extent of drug absorption into the circulation) of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared to the corresponding doses of single, separate injections of insulin degludec and liraglutide. Participants will receive all three test substances. The order of trial administration will be allocated by chance. During the trial period, serials of blood samples will be collected from the participants at three dosing periods, in order to determine the concentration of insulin degludec and liraglutide. The total volume of blood taken throughout the whole trial period will be less than 400 mL. Participants will be asked to stay on daytime and overnight in the trial sites on some predefined days. For other outpatient days, participants need to attend the trial site as required for drug administration or required assessments.
Interventions
DRUGinsulin degludec/liraglutide
Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the thigh.
DRUGinsulin degludec
17 U Insulin Degludec, single dose administration under the skin in the thigh.
DRUGliraglutide
0.6 mg Liraglutide, single dose administration under the skin in the thigh
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Intervention model description
Three-period complete cross-over, six treatment sequences
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female Chinese subjects, who are considered to be generally healthy, based on assessment of medical history, physical examination, and clinical laboratory data, as judged by the investigator * Age between 18 to 45 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 19.0 and 24.0 kg/sqm (both inclusive) * Body weight at least 50.0 kg * Fasting plasma glucose less than 6.1 mmol/L (110 mg/dL)
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive methods throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods * Donation of any blood or plasma in the past month or in excess of 400 mL within the 90 days preceding screening or surgery or trauma with more than 400 mL blood loss within the 90 days preceding screening * History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes and recurrent hypoglycaemia), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial result, as judged by the investigator * Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (mega-dose vitamin therapy not allowed, dose judged by the investigator) within 2 weeks prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the serum insulin degludec concentration time curve | From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours | Calculated based on insulin degludec concentration in serum |
| Area under the plasma liraglutide concentration time curve | from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours | Calculated based on liraglutide concentration in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum serum insulin degludec concentration | 0 hours to 120 hours | Calculated based on insulin degludec measured in serum |
| Terminal elimination half-life for insulin degludec | 0 hours to 120 hours | Calculated based on insulin degludec measured in serum |
| Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose | 0 hours to 72 hours | Calculated based on liraglutide measured in plasma |
| Maximum observed plasma liraglutide concentration | 0 hours to 72 hours | Calculated based on liraglutide measured in plasma |
| Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose | 0 hours to 120 hours | Calculated based on insulin degludec measured in serum |
| Terminal elimination half-life of liraglutide | 0 hours to 72 hours | Calculated based on liraglutide measured in plasma |
| Number of treatment emergent adverse events | Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit) | Count |
| Number of treatment emergent hypoglycaemic episodes | Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit) | Count |
| Local tolerability at the injection site | Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit) | Count |
| Time to maximum plasma liraglutide concentration | 0 hours to 72 hours | Calculated based on liraglutide measured in plasma |
| Maximum observed serum insulin degludec concentration | 0 hours to 120 hours | Calculated based on insulin degludec measured in serum |
Countries
China
Outcome results
None listed