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

NCT03292185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-11-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

insulin degludec/liraglutide

Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the thigh.

DRUG

insulin degludec

17 U Insulin Degludec, single dose administration under the skin in the thigh.

DRUG

liraglutide

0.6 mg Liraglutide, single dose administration under the skin in the thigh

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-29
Primary Completion
2018-01-02
Completion
2018-01-02
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03292185 on ClinicalTrials.gov