This Phase 2a, randomized, double-blind, active-controlled study will evaluate the safety, tolerability, and preliminary efficacy of TriGlytza®-01 compared with metformin in adults with Type 2 diabetes inadequately controlled despite metformin therapy. Participants will be randomized to one of three treatment groups and treated for 16 weeks. Safety, glycaemic control, body weight, and other metabolic outcomes will be assessed
Adults aged 18 to 70 years.
Confirmed diagnosis of Type 2 diabetes mellitus.
Inadequate glycaemic control while receiving a stable dose of metformin.
HbA1c within the protocol-defined screening range.
Type 1 diabetes mellitus or history of diabetic ketoacidosis.
Use of prohibited glucose-lowering medications before screening.
Clinically significant renal, hepatic, gastrointestinal, cardiovascular, or other medical conditions that could interfere with study participation or safety.
Recent major cardiovascular event or unstable cardiovascular disease.
Myopharm Limited
Lead sponsor
Southern Star Research
Collaborator