A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 800
- Locations
- 158
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
Arms & Interventions
Elecoglipron (one of the studied dose levels) + dapagliflozin
Participants will receive elecoglipron at one of the study dose levels in combination with dapagliflozin, administered orally once daily.
Intervention: Elecoglipron (Drug)
Elecoglipron dose level 1 + dapagliflozin-matched placebo
Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
Intervention: Elecoglipron (Drug)
Elecoglipron-matched placebo + dapagliflozin-matched placebo
Participants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily.
Intervention: Elecoglipron-matched placebo (Drug)
Elecoglipron (one of the studied dose levels) + dapagliflozin
Participants will receive elecoglipron at one of the study dose levels in combination with dapagliflozin, administered orally once daily.
Intervention: Dapagliflozin (Drug)
Elecoglipron dose level 2 + dapagliflozin-matched placebo
Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.
Intervention: Dapagliflozin-matched placebo (Drug)
Elecoglipron dose level 2 + dapagliflozin-matched placebo
Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.
Intervention: Elecoglipron (Drug)
Elecoglipron dose level 1 + dapagliflozin-matched placebo
Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
Intervention: Dapagliflozin-matched placebo (Drug)
Elecoglipron-matched placebo + dapagliflozin-matched placebo
Participants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily.
Intervention: Dapagliflozin-matched placebo (Drug)