Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 1, phase 2) is built around Liraglutide.

It had two arms (groups): Part 1: Open Label (experimental) and Part 2: Investigator blind (experimental).

The registry classes the interventions as drug.

More on the Plan

This Phase Ib/IIa study of SL liraglutide will be conducted at the Phase 1 Clinical Trial Center, Prince of Wales Hospital, Hong Kong.

Study subjects will be patients with T2DM who have not previously received liraglutide.

The study seeks to document the utility of a SL formulation of the approved active ingredient liraglutide, currently marketed in a subcutaneous (SC) formulation as Victoza®.

Who Took Part

The registry lists 15 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Males and females aged 18-65 years (inclusive). Body mass index (BMI) 18-35 kg/m2, inclusive. Normal blood pressure or well managed hypertension (systolic blood pressure \<160mmHg, diastolic blood pressure \<100 mmHg). Confirmed diagnosis of T2DM (by repeated laboratory findings) for at least 1 year. Vital signs after 10 minutes resting supine:.

The full record lists 19 inclusion and 29 exclusion criteria; among the exclusions: use of any weight loss agent within the preceding 4 weeks; surgery or hospitalization during the 4 weeks prior to screening; planned procedure or surgery during the study.

How the Study Was Run

The set-up was randomized, sequential and double-blind.

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

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2023-04-25 with completion listed for 2025-12.

It ran at 1 site in Hong Kong.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence, nature and severity of adverse events (time frame: Through study completion, an average of 6 weeks).

It also tracked 8 secondary outcomes, for example Peak Plasma Concentration (Cmax) for glucose, Area under the plasma concentration versus time curve (AUC) for glucose, Peak Plasma Concentration (Cmax) for C-peptide, Peak Plasma Concentration (Cmax) for insulin, Area under the plasma concentration versus time curve (AUC) for C-peptide and Area under the plasma concentration versus time curve (AUC) for insulin.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Liraglutide in 15 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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