A Phase 1 interventional study of insulin degludec/liraglutide and insulin degludec in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-18.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
Exclusion criteria:
Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide
Drug: insulin degludec/liraglutide · Drug: insulin degludec · Drug: liraglutide
Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec
Drug: insulin degludec/liraglutide · Drug: insulin degludec · Drug: liraglutide
Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide
Drug: insulin degludec/liraglutide · Drug: insulin degludec · Drug: liraglutide
Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide
Drug: insulin degludec/liraglutide · Drug: insulin degludec · Drug: liraglutide
Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide
Drug: insulin degludec/liraglutide · Drug: insulin degludec · Drug: liraglutide
Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec
Drug: insulin degludec/liraglutide · Drug: insulin degludec · Drug: 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.
17 U Insulin Degludec, single dose administration under the skin in the thigh.
0.6 mg Liraglutide, single dose administration under the skin in the thigh
Area under the serum insulin degludec concentration time curve
Calculated based on insulin degludec concentration in serum
Time frame: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours
Area under the plasma liraglutide concentration time curve
Calculated based on liraglutide concentration in plasma
Time frame: from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours
Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose
Calculated based on insulin degludec measured in serum
Time frame: 0 hours to 120 hours
Maximum observed serum insulin degludec concentration
Calculated based on insulin degludec measured in serum
Time frame: 0 hours to 120 hours
Time to maximum serum insulin degludec concentration
Calculated based on insulin degludec measured in serum
Time frame: 0 hours to 120 hours
Terminal elimination half-life for insulin degludec
Calculated based on insulin degludec measured in serum
Time frame: 0 hours to 120 hours
Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose
Calculated based on liraglutide measured in plasma
Time frame: 0 hours to 72 hours
Maximum observed plasma liraglutide concentration
Calculated based on liraglutide measured in plasma
Time frame: 0 hours to 72 hours
Time to maximum plasma liraglutide concentration
Calculated based on liraglutide measured in plasma
Time frame: 0 hours to 72 hours
Terminal elimination half-life of liraglutide
Calculated based on liraglutide measured in plasma
Time frame: 0 hours to 72 hours
Number of treatment emergent adverse events
Count
Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Number of treatment emergent hypoglycaemic episodes
Count
Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Local tolerability at the injection site
Count
Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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