Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With T
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).
| Condition(s) | Diabete Type 2 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 c |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Biolingus |
| Locations | Hong Kong, Hong Kong |
| Start date | 2023-04-25 |
| NCT ID | NCT05268237 |
| Official listing | https://clinicaltrials.gov/study/NCT05268237 |