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The main purpose of the trial is to compare the pharmacokinetics of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared with Xultophy®. During the trial period, serials of blood samples will be collected from the participants at two 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Experimental |
| |
| Xultophy® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/liraglutide | Drug | Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the abdomen. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma insulin degludec concentration | Calculated based on insulin degludec measured in plasma | 0 hours to 120 hours |
| Maximum observed plasma liraglutide concentration | Calculated based on liraglutide measured in plasma | 0 hours to 72 hours |
| Area under the plasma insulin degludec concentration time curve | Calculated based on insulin degludec concentration in plasma | From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide, assessments from 0 hours to 120 hours |
| Area under the plasma liraglutide concentration time curve | Calculated based on liraglutide concentration in plasma | From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide, assessments from 0 hours to 72 hours |
| Area under the plasma insulin degludec concentration time curve from 0 to infinity after single dose | Calculated based on insulin degludec measured in plasma | 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 | 0 hours to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum plasma insulin degludec concentration | Calculated based on insulin degludec measured in plasma | 0 hours to 120 hours |
| Time to maximum plasma liraglutide concentration | Calculated based on liraglutide measured in plasma |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of Jilin University | Recruiting | Jilin City | China |
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| ID | Term |
|---|---|
| C000613158 | IDegLira |
| C000629636 | Xultophy |
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| Xultophy® | Drug | Xultophy® |
|
| 0 hours to 72 hours |
| Terminal elimination half-life for insulin degludec | Calculated based on insulin degludec measured in plasma | 0 hours to 120 hours |
| Terminal elimination half-life for liraglutide | Calculated based on liraglutide measured in plasma | 0 hours to 72 hours |
| Apparent clearance for insulin degludec | Calculated based on insulin degludec measured in plasma | 0 hours to 120 hours |
| Apparent clearance for liraglutide | Calculated based on liraglutide measured in plasma | 0 hours to 72 hours |
| Apparent volume of distribution for insulin degludec | Calculated based on insulin degludec measured in plasma | 0 hours to 120 hours |
| Apparent volume of distribution for liraglutide | Calculated based on liraglutide measured in plasma | 0 hours to 72 hours |
| Area under the plasma insulin degludec concentration time curve | Calculated based on insulin degludec concentration in plasma | 0 hours to 24 hours |
| Number of treatment emergent adverse events | Count | From the first drug administration to the follow-up visit (6 to 13 days after the last drug administration) |
| Number of treatment emergent hypoglycaemic episodes | Count | From the first drug administration to the follow-up visit (6 to 13 days after the last drug administration) |
| Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration) | Count | From the first drug administration to the follow-up visit (6 to 13 days after the last drug administration) |