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

Sponsor
Biolingus
Study ID
NCT05268237
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Diabete Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Sublingual or subcutaneous liraglutide
  • Placebo — DRUG
    Sublingual placebo

Study Details

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).

Key Dates

Start date
Apr 25, 2023
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Open Label
    Part 1 of the trial will utilise an open label, single ascending dose, repeated treatment design. It will involve 3 subjects, each of whom will receive three single ascending doses of SL liraglutide (3, 12, 30mg and subcutaneous (SC) liraglutide (active comparator) with a mixed meal tolerance test (MMTT), separated by 1 week washout between doses.
  • Experimental: Part 2: Investigator blind
    Part 2 of the trial will utilise an investigator-blind, sponsor open, placebo-controlled, randomised, repeated treatment study design. It will involve 12 subjects. Each subjects will receive one of three possible doses of SL-liraglutide (to be decided by the Safety Monitoring Committee following analysis of the results from Part 1), SL-placebo or SC liraglutide in a randomised order with MMTT separated by 1 week washout between doses.

Primary Outcome Measure

Incidence, nature and severity of adverse events [ Time Frame: Through study completion, an average of 6 weeks ]

Central Contacts

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