A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
- Conditions
- Diabetes Mellitus, Type 2Diabetes
- Interventions
- Registration Number
- NCT03292185
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IDeg-Liraglutide-IDeglira insulin degludec/liraglutide Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide Liraglutide-IDeg-IDeglira insulin degludec/liraglutide Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide IDeglira-IDeg-Liraglutide insulin degludec/liraglutide Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide Liraglutide-IDeglira-IDeg insulin degludec/liraglutide Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec IDeglira-Liraglutide-IDeg insulin degludec/liraglutide Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec IDeg-IDeglira-Liraglutide insulin degludec/liraglutide Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide Liraglutide-IDeg-IDeglira insulin degludec Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide IDeglira-IDeg-Liraglutide insulin degludec Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide IDeglira-IDeg-Liraglutide liraglutide Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide IDeglira-Liraglutide-IDeg insulin degludec Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec IDeglira-Liraglutide-IDeg liraglutide Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec IDeg-Liraglutide-IDeglira insulin degludec Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide IDeg-Liraglutide-IDeglira liraglutide Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide IDeg-IDeglira-Liraglutide insulin degludec Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide IDeg-IDeglira-Liraglutide liraglutide Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide Liraglutide-IDeg-IDeglira liraglutide Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide Liraglutide-IDeglira-IDeg insulin degludec Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec Liraglutide-IDeglira-IDeg liraglutide Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Time to maximum 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
Maximum observed serum insulin degludec concentration 0 hours to 120 hours Calculated based on insulin degludec measured in serum
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
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
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇳Beijing, Beijing, China