The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
800
Elecoglipron is administered orally once daily.
Dapagliflozin administered orally once daily.
A placebo matching elecoglipron, administered orally once daily.
Change 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 ≥5% weight loss from baseline
Time frame: Baseline to Week 40
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline to Week 40
Time to initiation of rescue medication over 40 weeks
Time frame: Baseline to Week 40
AstraZeneca Clinical Study Information Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
A placebo matching dapagliflozin, administered orally once daily.
Research Site
Birmingham, Alabama, United States
NOT_YET_RECRUITINGResearch Site
Daphne, Alabama, United States
NOT_YET_RECRUITINGResearch Site
Lomita, California, United States
NOT_YET_RECRUITINGResearch Site
Los Alamitos, California, United States
NOT_YET_RECRUITINGResearch Site
San Diego, California, United States
SUSPENDEDResearch Site
Walnut Creek, California, United States
SUSPENDEDResearch Site
Englewood, Colorado, United States
NOT_YET_RECRUITINGResearch Site
Bridgeport, Connecticut, United States
NOT_YET_RECRUITINGResearch Site
Jacksonville, Florida, United States
NOT_YET_RECRUITINGResearch Site
Orlando, Florida, United States
NOT_YET_RECRUITING...and 139 more locations