Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5683
Source ID: NCT05268237
Associated Drug: Liraglutide
Title: Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabete Type 2
Interventions: DRUG: Liraglutide|DRUG: Placebo
Outcome Measures: Primary: Incidence, nature and severity of adverse events, The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of SL liraglutide in subjects with Type II Diabetes Mellitus (T2DM), and the primary outcome measures are therefore the incidence, nature and severity of adverse events, including those that are serious, dose limiting or of special interest., Through study completion, an average of 6 weeks | Secondary: Peak Plasma Concentration (Cmax) for glucose, A secondary objective is to document the pharmacodynamic effect of SL liraglutide through a mixed meal tolerance test (MMTT) following single ascending dosing in treated subjects., 5 hours following administration of the study drug|Area under the plasma concentration versus time curve (AUC) for glucose, A secondary objective is to document the pharmacodynamic effect of SL liraglutide through a mixed meal tolerance test (MMTT) following single ascending dosing in treated subjects., 5 hours following administration of the study drug|Peak Plasma Concentration (Cmax) for C-peptide, A secondary objective is to document the pharmacodynamic effect of SL liraglutide through a mixed meal tolerance test (MMTT) following single ascending dosing in treated subjects., 5 hours following administration of the study drug|Peak Plasma Concentration (Cmax) for insulin, A secondary objective is to document the pharmacodynamic effect of SL liraglutide through a mixed meal tolerance test (MMTT) following single ascending dosing in treated subjects., 5 hours following administration of the study drug|Area under the plasma concentration versus time curve (AUC) for C-peptide, A secondary objective is to document the pharmacodynamic effect of SL liraglutide through a mixed meal tolerance test (MMTT) following single ascending dosing in treated subjects., 5 hours following administration of the study drug|Area under the plasma concentration versus time curve (AUC) for insulin, A secondary objective is to document the pharmacodynamic effect of SL liraglutide through a mixed meal tolerance test (MMTT) following single ascending dosing in treated subjects., 5 hours following administration of the study drug|Insulin secretion rate (ISR), A secondary objective is to document the pharmacodynamic effect of SL liraglutide through a mixed meal tolerance test (MMTT) following single ascending dosing in treated subjects., 5 hours following administration of the study drug|Serum concentration of liraglutide, A secondary objective is to determine the pharmacokinetics (PK) of SL-liraglutide in plasma following single ascending dosing in treated subjects., 5 hours following administration of the study drug
Sponsor/Collaborators: Sponsor: Biolingus | Collaborators: Chinese University of Hong Kong
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 15
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-04-25
Completion Date: 2026-03
Results First Posted:
Last Update Posted: 2025-02-06
Locations: Clinical Trials Unit, Chinese University of Hong Kong, Hong Kong, Hong Kong
URL: https://clinicaltrials.gov/show/NCT05268237