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

Sponsor
Novo Nordisk A/S
Study ID
NCT03292185
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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

Study Details

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.

Key Dates

Start date
Sep 29, 2017
Status verified
Nov 2019
Primary completion
Jan 2, 2018
Completion
Jan 2, 2018

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: IDeglira-IDeg-Liraglutide
    Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide
  • Experimental: IDeglira-Liraglutide-IDeg
    Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec
  • Experimental: IDeg-Liraglutide-IDeglira
    Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide
  • Experimental: IDeg-IDeglira-Liraglutide
    Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide
  • Experimental: Liraglutide-IDeg-IDeglira
    Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide
  • Experimental: Liraglutide-IDeglira-IDeg
    Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec

Primary Outcome Measure

Area under the serum insulin degludec concentration time curve [ Time Frame: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours ]

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