CX11 for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Adults aged 18-75 with type 2 diabetes, not well-controlled on metformin (with or without SGLT2 inhibitors), can join this trial. They should have an HbA1c between 7.0% and 10.5%, a BMI of 23-50 kg/m², and stable body weight for the past three months. Participants must use effective birth control if they can conceive.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a randomized dose of CX11 or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CX11
Trial Overview
The study tests CX11 tablets' effectiveness and safety in managing blood sugar levels compared to a placebo over a period of 24 weeks, followed by a safety check after two weeks. It's randomized and double-blind, meaning neither participants nor staff know who gets the real drug or placebo.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corxel Pharmaceuticals
Lead Sponsor
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