A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients with Type 2 Diabetes Mellitus.
Phase 2 – studying effectiveness and dosage
Conditions:
Type 2 Diabetes Mellitus
Sponsor: Corxel Pharmaceuticals Inc.
trial.available_in:
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Overview
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
Description
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
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 121 participants
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