A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients with Type 2 Diabetes Mellitus.
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Type 2 Diabetes Mellitus
Спонсор: Corxel Pharmaceuticals Inc.
Налично на:
БГ
Обобщение
Trial status: Authorised
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
Change in HbA1c from baseline
Описание
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
Кой може да участва
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 121 participants