RecruitingPhase 1Phase 2NCT05268237

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


Sponsor

Biolingus

Enrollment

15 participants

Start Date

Apr 25, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new under-the-tongue (sublingual) form of liraglutide — a medication already used by injection for type 2 diabetes — to see if it is safe and effective when taken by mouth. **You may be eligible if...** - You are 18–65 years old - You have had type 2 diabetes for at least 1 year - Your BMI is between 18 and 35 - You control your diabetes with metformin alone, or with diet and exercise only - Your blood pressure is reasonably controlled **You may NOT be eligible if...** - You use insulin or other diabetes medications beyond metformin - Your blood pressure is not well controlled (above 160/100) - Your BMI is above 35 - You have significant heart, kidney, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiraglutide

Sublingual or subcutaneous liraglutide

DRUGPlacebo

Sublingual placebo


Locations(1)

Clinical Trials Unit, Chinese University of Hong Kong

Hong Kong, Hong Kong

View Full Details on ClinicalTrials.gov

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NCT05268237


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