Last updated 13 days ago
A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus
1200 patients around the world
Available in United States, Brazil, Argentina
AstraZeneca
1200Patients 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(s).HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol).Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors.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 Mellitus (T1DM), 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 Gastrointestinal (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 (NYHA IV).History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.
StudyEluminate-2
SponsorAstraZeneca
Study typeInterventional
Conditions
Diabetes mellitus type 2
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07662213
