A Phase 2, Double-Blind, Placebo-Controlled, Randomised, Single Dose, Crossover Study to Investigate the Glucose Lowering of PSN821 in Patients with Type 2 Diabetes (T2DM) after an Ensure Plus challenge

INTERVENTION: Product Name: PSN821AA Product Code: PSN821AA Pharmaceutical Form: Oral suspension Current Sponsor code: PSN821AA Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use CONDITION: Type 2 Diabetes mellitus ; MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus PRIMARY OUTCOME: Main Objective: • To compare the pharmacodynamic response of single oral doses of PSN821 following a; MMTT (based on the area under the glucose concentration‐time curve from 1‐6 hours; post‐dose, i.e. from 0‐5 hours after a MMTT); • To establish the dose response relationship for the glucose lowering effect of PSN821; using reactive glucose area under the curve (AUC) Primary end point(s): The primary (PD) endpoint of the study is:; ‐ AUCPG(5h) area under the plasma glucose concentration‐time profile from 1‐6 hours postdose (i.e. from 0‐5 hours after a MMTT) Secondary Objective: • To compare other pharmacodynamic properties (based on glucose, insulin and C‐peptide; measurements) of single oral doses of PSN821 before and following a MMTT; • To compare the pharmacokinetic (PK) exposure and properties of each single oral dose; for 12h post‐dosing; • To assess the PK/PD relationship (based on AUC PSN821 and AUC glucose); • To assess the short‐term safety after single oral dosing INCLUSION CRITERIA: 1. Signed and dated written informed consent obtained before any study‐related activities 2. Male and female patients with a diagnosis of type 2 diabetes mellitus according to ADA criteria at least 4 months prior to screening 3. Medical history without major pathology (with the exception of type 2 diabetes) 4. On a stable regimen of metformin monotherapy (minimum of 850 mg/day) prior to screening (medication type and dose unchanged for the last 3 months) 5. Aged between 18 and 65 years of age, both inclusive 6. Body mass index (BMI) between 25 and 40kg/m2, both inclusive 7. HbA1c between 6.8 and 9.5 %, both inclusive 8. Fasting plasma glucose (FPG) between 126 and 270 mg/dL (7‐15 mmol/L), both inclusive 9. A female patient is eligible to participate if she is of: Non‐childbearing potential defined as pre‐menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous

Epistemonikos ID: d010bd0b8ca92929af7b2906b0c9b2cbf22cf7f9
First added on: Aug 22, 2024