Actively Recruiting
Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus
Led by Biolingus · Updated on 2025-02-06
15
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
B
Biolingus
Lead Sponsor
C
Chinese University of Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18-65 years (inclusive)
- Body mass index (BMI) between 18 and 35 kg/m2
- Normal blood pressure or well managed hypertension (systolic <160 mmHg, diastolic <100 mmHg)
- Confirmed diagnosis of type 2 diabetes mellitus for at least 1 year
- Glycemic control with stable metformin dose up to 2 g daily for at least 2 months or managed by diet/exercise only
- Stable metformin dose or stable diet/exercise management with no changes allowed until study completion
- Fasting plasma glucose ≥ 5.6 mmol/L at screening
- HbA1c between 6.5% and 9.0% at screening
- Vital signs within specified ranges after 10 minutes resting supine
- Standard 12-lead ECG within specified parameters at screening
- No significant cardiovascular disease in the past 3 years except well managed hypertension
- Negative drug abuse test at screening and admission
- Females must be non-pregnant, non-lactating, and use effective contraception or be post-menopausal
- Women of child-bearing potential must have negative pregnancy tests and agree to additional tests
- Males must be surgically sterile, abstinent, or use effective contraception if with female partners
- Males must agree to refrain from sperm donation during the study
You will not qualify if you...
- Pregnant, lactating, or intending pregnancy within 30 days after last dose
- Participation in another clinical trial or use of experimental therapies within specified timeframes
- Any vaccine within 2 weeks before first dose until 2 weeks after last dose, except seasonal flu vaccine
- Use of weight loss agents within 4 weeks prior to screening
- Surgery or hospitalization within 4 weeks prior to screening or planned during study
- Blood transfusion within 8 weeks prior to screening
- Donation or loss of ≥300 mL blood within 30 days before dosing
- Poor peripheral venous access
- Alcohol or substance abuse in past 2 years
- Unstable or significant cardiovascular disease within last 2 years
- History of pancreatitis
- Clinically significant abnormal ECG or prior myocardial infarction within 2 years
- History or risk factors for ventricular dysrhythmias
- Impaired liver function or clinically significant synthetic function abnormalities
- Unstable thyroid conditions
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia Type 2
- Current or past bulimia or anorexia nervosa
- Severe allergies or known sensitivities to study drug components
- Diagnosis of type 1 diabetes or previous diabetic ketoacidosis
- History of inflammatory bowel disease or diabetic gastroparesis
- Severe hypoglycemia requiring hospitalization in last 3 months
- Persistent hyperglycemia not controlled by metformin or diet/exercise
- Proliferative retinopathy, nephropathy, or significant renal impairment
- Any serious medical condition or lab abnormality increasing risk or interfering with study
- Use of diabetes medications other than metformin at screening or before dosing
- Use of certain diabetes medications (DPP-4 inhibitors, GLP-1 agonists, SGLT2 inhibitors, insulin, thiazolidinediones, acarbose) in past 3 months
- Unwilling or unable to follow study protocol requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinical Trials Unit, Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
E
Elaine YK Chow
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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