Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100032, China
NCT Number: NCT03292185
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 100032, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Calculated based on insulin degludec concentration in serum
Time frame: 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
Time frame: 0 hours to 120 hours
Calculated based on insulin degludec measured in serum
Time frame: 0 hours to 120 hours
Calculated based on insulin degludec measured in serum
Time frame: 0 hours to 120 hours
Calculated based on insulin degludec measured in serum
Time frame: 0 hours to 120 hours
Calculated based on insulin degludec measured in serum
Time frame: 0 hours to 72 hours
Calculated based on liraglutide measured in plasma
Time frame: 0 hours to 72 hours
Calculated based on liraglutide measured in plasma
Time frame: 0 hours to 72 hours
Calculated based on liraglutide measured in plasma
Time frame: 0 hours to 72 hours
Calculated based on liraglutide measured in plasma
Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
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Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
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Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
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Novo Nordisk A/S
Industry
A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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