Last updated 4 days ago
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin
900 patients around the world
Available in United States, Mexico
AstraZeneca
900Patients around the world
This study is for people with
Diabetes
Diabetes mellitus type 2
Renal disease
Chronic kidney disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening.On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s).HbA1c value.On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol).SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol).Impaired renal function.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-4
SponsorAstraZeneca
Study typeInterventional
Conditions
Diabetes mellitus type 2Chronic kidney disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07662135
