Last updated 13 days ago

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

2000 patients around the world

Available in Puerto Rico, United States, Brazil, Argentina

AstraZeneca

2000Patients around the world

This study is for people with

Diabetes

Diabetes mellitus type 2

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: 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.

: 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.

StudyEluminate-5

SponsorAstraZeneca

Study typeInterventional

Conditions

Diabetes mellitus type 2

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07662109