RecruitingType 2 Diabetes MellitusType 2 Diabetes With Chronic Kidney Disease

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

Eligible age

18+ yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).

Sponsor: AstraZeneca

You may qualify if…

✓ 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:
✓ 1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
✓ 2. 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

You may not qualify if…

✕ 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