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

What Was Tested

The trial (phase 1) is built around Liraglutide.

It had two arms (groups): Insulin Degludec/Liraglutide (experimental) and Xultophy® (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 44 planned participants were the target.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subjects signed and dated Informed consent form (ICF) before having a full understanding of the study contents and procedures and potential adverse reactions for the study;. Subjects are able to communicate well with the investigator and complete the study;. Healthy Chinese subjects aged 18 to 45 years (inclusive), male or female;. Body Mass Index (BMI) ≥ 19 kg/m2 and ≤ 26kg/m2 at screening, male weight ≥ 50 kg, females weight≥ 45 kg;.

The full record lists 7 inclusion and 23 exclusion criteria; among the exclusions: females breast-feeding, or females with a positive blood pregnancy test result at screening;; A history of diabetes mellitus in the past;; A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2;.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2024-05-06 with completion listed for 2024-06-16.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maximum observed plasma insulin degludec concentration (time frame: 0 hours to 120 hours). Maximum observed plasma liraglutide concentration (time frame: 0 hours to 72 hours). Area under the plasma insulin degludec concentration time curve.

It also tracked 12 secondary outcomes, for example Time to maximum plasma insulin degludec concentration, Time to maximum plasma liraglutide concentration, Terminal elimination half-life for insulin degludec, Terminal elimination half-life for liraglutide, Apparent clearance for insulin degludec and Apparent clearance for liraglutide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 44 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.