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NCT03292185Completed

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

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
Novo Nordisk A/SPhase 1ClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
insulin degludec/liraglutide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Novo Nordisk A/S
Location
Beijing, China
Timeline & enrollment
Phase
Phase 1
Start date
Sep 29, 2017
End date
Jan 02, 2018
Enrollment
24 participants
Primary outcome

Area under the serum insulin degludec concentration time curve,Area under the plasma liraglutide concentration time curve

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.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03292185
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03292185 through Pure Global AI's free database. This Phase 1 trial is sponsored by Novo Nordisk A/S and is currently Completed. The study focuses on Diabetes,Diabetes Mellitus, Type 2. Target enrollment is 24 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.