Pure Global

A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects - Trial NCT03292185

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT03292185
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT03292185
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

insulin degludec/liraglutide

Interventional

drug

Sponsor & Location

Novo Nordisk A/S

Beijing, China

Timeline & Enrollment

Phase 1

Sep 29, 2017

Jan 02, 2018

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 mellitus
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT03292185

Non-Device Trial