The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
900
Elecoglipron is administered orally once daily.
Placebo is administered orally once daily.
Research Site
Sun City, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Surprise, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Concord, California, United States
NOT_YET_RECRUITINGResearch Site
Sacramento, California, United States
RECRUITINGChange from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline to Week 40
Achievement of HbA1c < 7% (53 mmol/mol)
Time frame: Week 40
Achievement of HbA1c ≤ 6.5% (48 mmol/mol)
Time frame: Week 40
Percent change in body weight
Time frame: Baseline to Week 40
Change from baseline in body weight
Time frame: Baseline to Week 40
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline to Week 40
Achievement of HbA1c < 7% (53 mmol/mol) without hypoglycemia (glucose < 54 mg/dL (3.0 mmol/L) or severe hypoglycemia)
Time frame: Baseline to Week 40
Change from baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline to Week 40
Time to initiation of rescue medication over 40 weeks
Time frame: Baseline to Week 40
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline to Week 40
AstraZeneca Clinical Study Information Center
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Research Site
Victorville, California, United States
NOT_YET_RECRUITINGResearch Site
Fleming Island, Florida, United States
NOT_YET_RECRUITINGResearch Site
Lauderdale Lakes, Florida, United States
NOT_YET_RECRUITINGResearch Site
Leesburg, Florida, United States
NOT_YET_RECRUITINGResearch Site
Miami Lakes, Florida, United States
RECRUITINGResearch Site
Ocoee, Florida, United States
RECRUITING...and 176 more locations