A Trial Investigating the Efficacy and Safety of Insulin Degludec/Liraglutide Injection in Subjects With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

This is a randomised, open-label, multicenter, active-controlled, parallel-design, phase III clinical trial.

It had two arms (groups): Insulin Degludec/liraglutide injection (experimental) and XULTOPHY® (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 510 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects who voluntarily participate in this clinical trial and signed the informed consent form (ICF);. Chinese subjects aged 18-75 years (both inclusive) at the time of consent, male or female;. Type 2 diabetes mellitus (clinically diagnosed for more than 6 months);. Body mass index (BMI) ≥ 19.0 kg/m2 and ≤ 40 kg/m2;. Able and willing to adhere to the protocol including performing self-monitoring of plasma glucose profiles, keeping a trial diary and using a pre-filled pen device.

The full record lists 13 inclusion and 14 exclusion criteria; among the exclusions: subjects with diabetes of other types than t2dm;; known or suspected hypersensitivity to trial product(s) or related components;; participated in any clinical trial and receipt of any treatment of investigational medicinal product (imp) or medical device within 90 days prior screening;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-08 with completion listed for 2025-10.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline in HbA1c after 26 weeks of treatment (time frame: Baseline, Week 26).

It also tracked 10 secondary outcomes, for example Changes from baseline in fasting plasma glucose (FPG) after 12, 26 weeks of treatment, Change from baseline in 7-point SMBG values after 12, 26 weeks of treatment, Change from baseline in body weight after 12, 26 weeks of treatment, Number of treatment emergent adverse events, Number of treatment emergent hypoglycaemic episodes and Number of participants with injection site reactions.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 510 people.

With 510 participants it is a large trial for this field.

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.