drugset / Trial / NCT03292185

A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects

NCT03292185

Phase 1 Completed 24 enrolled Novo Nordisk A/S
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2017-09-29
Primary completion
2018-01-02
Completion
2018-01-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Liraglutide Peptide 0.6 mg Subcutaneous
Subject Liraglutide Peptide 0.61 mg Subcutaneous
Subject insulin degludec Protein / enzyme biologic 17 iu Subcutaneous