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

Purpose

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).

Conditions

  • Type 2 Diabetes Mellitus
  • Type 2 Diabetes With Chronic Kidney Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Elecoglipron dose level 1 		Participants will receive elecoglipron at dose level 1, administered orally once daily, in addition to background dapagliflozin 10 mg.
  • Drug: Elecoglipron
    Elecoglipron is administered orally once daily.
Experimental
Elecoglipron dose level 2 		Participants will receive elecoglipron at dose level 2, administered orally once daily, in addition to background dapagliflozin 10 mg.
  • Drug: Elecoglipron
    Elecoglipron is administered orally once daily.
Placebo Comparator
Placebo 		Participants will receive placebo administered orally once daily in addition to background dapagliflozin 10 mg.
  • Drug: Placebo
    Placebo is administered orally once daily.

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com