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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1155-0990 | Other Identifier | World Health Organization (WHO) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeglira-IDeg-Liraglutide | Experimental | Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide |
|
| IDeglira-Liraglutide-IDeg | Experimental | Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec |
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| IDeg-Liraglutide-IDeglira | Experimental | Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide |
|
| IDeg-IDeglira-Liraglutide | Experimental | Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide |
|
| Liraglutide-IDeg-IDeglira | Experimental | Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide |
| 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 thigh. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin degludec concentration time curve | Calculated based on insulin degludec concentration in serum | 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 | from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose | Calculated based on insulin degludec measured in serum | 0 hours to 120 hours |
| Maximum observed serum insulin degludec concentration |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100032 | China |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Three-period complete cross-over, six treatment sequences
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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| Liraglutide-IDeglira-IDeg | Experimental | Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec |
|
| insulin degludec | Drug | 17 U Insulin Degludec, single dose administration under the skin in the thigh. |
|
| liraglutide | Drug | 0.6 mg Liraglutide, single dose administration under the skin in the thigh |
|
Calculated based on insulin degludec measured in serum
| 0 hours to 120 hours |
| Time to maximum serum insulin degludec concentration | Calculated based on insulin degludec measured in serum | 0 hours to 120 hours |
| Terminal elimination half-life for insulin degludec | Calculated based on insulin degludec measured in serum | 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 |
| Maximum observed plasma liraglutide concentration | Calculated based on liraglutide measured in plasma | 0 hours to 72 hours |
| Time to maximum plasma liraglutide concentration | Calculated based on liraglutide measured in plasma | 0 hours to 72 hours |
| Terminal elimination half-life of liraglutide | Calculated based on liraglutide measured in plasma | 0 hours to 72 hours |
| Number of treatment emergent adverse events | Count | Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit) |
| Number of treatment emergent hypoglycaemic episodes | Count | Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit) |
| Local tolerability at the injection site | Count | Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000613158 | IDegLira |
| C571886 | insulin degludec |
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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