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

Summary

This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.

Eligibility

Age range

18–75 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  CX11

  CX11 tablets administered orally once daily (QD)

• Other
  Placebo

  Matching placebo tablets administered orally once daily (QD)

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