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A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus

NCT07662109

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Type 2 Diabetes Mellitus

Interventions: Elecoglipron, Dapagliflozin, Elecoglipron-matched placebo, Dapagliflozin-matched placebo

Countries: United States, Argentina, Brazil, China, Czechia, Denmark, Germany, Greece

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
* T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
* HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
* Body mass index (BMI) of ≥ 23 kg/m2 at screening
* Stable body weight (self-reported or documented) for 90 days prior to screening

Exclusion Criteria:

* Type 1 Diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
* Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
* Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
* Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
* History of acute or chronic pancreatitis
* Severe congestive heart failure (New York Heart Association IV)
* History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Locations (272)

Huntsville, Alabama, United States
Mobile, Alabama, United States
Sheffield, Alabama, United States
Little Rock, Arkansas, United States
Bakersfield, California, United States
Los Angeles, California, United States
Ontario, California, United States
Lake City, Florida, United States
Lakeland, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Evansville, Indiana, United States
Sioux City, Iowa, United States
Zachary, Louisiana, United States
Annapolis, Maryland, United States
Lutherville-Timonium, Maryland, United States
Oxon Hill, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Troy, Michigan, United States
Ridgeland, Mississippi, United States
Elkhorn, Nebraska, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Raleigh, North Carolina, United States
Beachwood, Ohio, United States
Maumee, Ohio, United States
Norman, Oklahoma, United States
Kingsport, Tennessee, United States
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