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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
CX11 tablets administered orally once daily (QD)
Matching placebo tablets administered orally once daily (QD)
Central Research Associates - Flourish - PPDS
Birmingham, Alabama, United States
AES - DRS - Synexus Clinical Research US, Inc. - Birmingham
Birmingham, Alabama, United States
AES - DRS - Optimal Research Alabama - Huntsville
Huntsville, Alabama, United States
Ark Clinical Research - Long Beach
Long Beach, California, United States
Flourish Research - Walnut Creek - PPDS
Walnut Creek, California, United States
Change in Glycosylated hemoglobin, Type A1C (HbA1c) from baseline
Time frame: At Week 24
Proportion of participants achieving HbA1c < 7.0%
Time frame: At Week 24
Proportion of participants achieving HbA1c ≤ 6.5%
Time frame: At Week 24
Change from baseline in Time in Range (TIR) measured by Continuous Glucose Monitoring (CGM)
Time frame: To Week 24
Change from baseline in fasting plasma glucose (FPG)
Time frame: To Week 24
Change in body weight from baseline
Time frame: To Week 24
Percent change in body weight from baseline
Time frame: To Week 24
Proportion of participants achieving body weight loss ≥ 5%
Time frame: At Week 24
Proportion of participants achieving body weight loss ≥ 10%
Time frame: At Week 24
Change in Systolic Blood Pressure (SBP) from baseline
Time frame: To Week 24
Change in Diastolic Blood Pressure (DBP) from baseline
Time frame: To Week 24
Number of Level 2 hypoglycemic episodes (glucose <54 mg/dL)
Time frame: To Week 24
Number of severe hypoglycemic episodes
Time frame: To Week 24
Number of treatment-emergent adverse events (TEAEs)
Time frame: Study duration, approximately 26 weeks
Number of AEs of special interest (AESIs)
Time frame: Study duration, approximately 26 weeks
Plasma drug concentrations at each specified sampling time point
Time frame: At Weeks 2, 4, 6, 8, 12, 16, 22 and 24
Mean plasma drug concentration at each specified sampling time point
Time frame: At Weeks 2, 4, 6, 8, 12, 16, 22 and 24
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AES - DRS - Optimal Research Florida - Melbourne
Melbourne, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Conquest Research LLC - Winter Park
Winter Park, Florida, United States
Privia Medical Group Georgia, LLC - Albany - Javara - PPDS
Albany, Georgia, United States
Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
Savannah, Georgia, United States
...and 36 more locations