A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients with Type 2 Diabetes Mellitus.

Condition studied

Type 2 Diabetes Mellitus

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change in HbA1c from baseline

Endpoint detail

1. HbA1c < 7.0% 2. HbA1c ≤ 6.5% 3. Change of TIR on CGM from baseline 4. Change in FPG from baseline 5. Change in body weight from baseline 6. Percent change in body weight from baseline 7. Body weight loss ≥ 5% 8. Body weight loss ≥ 10% 8. Body weight loss ≥ 10%, 9. Change in SBP and DBP from baseline 10. Number of level 2 hypoglycemic episodes or severe hypoglycemic episodes 11. TEAE & AESI; 12. Population PK parameters