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Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

A Phase Ib/IIa, Single Ascending Dose Study of the Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus

NCT05268237•Biolingus

View on ClinicalTrials.gov

Summary

This is a phase Ib/IIa, single ascending dose study of the safety, tolerability and preliminary efficacy of sublingual (SL) Liraglutide in patients with type 2 diabetes mellitus (T2DM).

Detailed Description

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®.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females aged 18-65 years (inclusive)
•2. Body mass index (BMI) 18-35 kg/m2, inclusive
•3. Normal blood pressure or well managed hypertension (systolic blood pressure \<160mmHg, diastolic blood pressure \<100 mmHg)
•4. Confirmed diagnosis of T2DM (by repeated laboratory findings) for at least 1 year.
•5. Subjects under glycemic control on a stable dose of metformin (within the standard of care dose range up to 2 g daily) for at least 2 months prior to enrolment or those who manage their condition only by diet/exercise.
•6. For subjects on a stable dose of concomitant metformin for at least 2 months prior to enrolment, the subject's dose of metformin will be required to remain constant until at least the completion of MMTT on the final dosing day. Subjects whose concomitant glucose lowering medication changes during the dosing phase of the study will be discontinued and may be replaced.
•7. For subjects not in receipt of concomitant metformin for at least 2 months prior to enrolment, and who manage their condition only by diet/exercise, documentation of stable glycemic control under current condition management for at least 2 months prior to enrolment, as confirmed by HbA1c. For subjects who meet this criterion, no change in disease management is permitted until at least the completion of MMTT on the final dosing day. Any subject who requires a change in disease management, including initiation of any diabetes medication during the study, will be discontinued from the study and may be replaced.
•8. Fasting plasma glucose ≥5.6 mmol/L at screening
•9. HbA1c ≥6.5% and ≤9.0% at screening
•10. Vital signs after 10 minutes resting supine:
+11 more criteria

Exclusion Criteria

•1. Pregnant or lactating, or intending to become pregnant within 30 days after last dose of study drug.
•2. Participation in a clinical trial within 30 days before enrolment; use of any experimental oral therapy within 30 days or 5 half-lives prior to enrolment, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to enrolment, whichever is greater. Subjects who have received an experimental therapy that has no half-life, such as a vaccine, should have completed that therapy at least 30 days prior to enrolment.
•3. Any vaccine 2 weeks prior to first study drug administration until 2 weeks after the last dose, with the exception of current seasonal influenza vaccination.
•4. Use of any weight loss agent within the preceding 4 weeks.
•5. Surgery or hospitalization during the 4 weeks prior to screening.
•6. Planned procedure or surgery during the study.
•7. Blood transfusion within 8 weeks prior to screening.
•8. Donation or loss of blood (excluding the volume of blood that will be drawn during screening procedures) as follows: ≥ 300 mL of blood within 30 days prior to study drug administration.
•9. Poor peripheral venous access.
•10. Alcohol and/or substance abuse or dependence within the past 2 years.
+16 more criteria

Locations (1)

Clinical Trials Unit, Chinese University of Hong Kong

Hong Kong, Hong Kong

Key Dates

Start Date

April 25, 2023

Primary Completion Date

December 1, 2025

Completion Date

March 1, 2026

Last Updated

February 6, 2025

Enrollment

ESTIMATED participants

Conditions

Diabete Type 2

Interventions

Liraglutide

DRUG

Placebo

DRUG

Contacts

Elaine YK Chow

CONTACT

+852 35051642 e.chow@cuhk.edu.hk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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