Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus
Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
Adult males and females, 18 to 75 years of age (inclusive) on the day of signing the informed consent form (ICF).
Must have a diagnosis of T2DM for at least 6 months before screening based on the disease diagnostic criteria.
Must have an HbA1c value at screening of ≥7.0% and ≤10.0% (≥53 and ≤86 mmol/mol) and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000 mg/day and not more than the locally approved dose) for at least 3 months prior to screening.
Have a diagnosis of type 1 diabetes.
History of severe hypoglycaemia and/or hypoglycaemia unawareness within 6 months prior to screening.
Have active proliferative diabetic retinopathy or history of uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
History of or current chronic pancreatitis, or acute pancreatitis within the past 6 months prior to screening.