A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus

Purpose

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.

Condition

  • Type 2 Diabetes Mellitus

Eligibility

Eligible Ages
Over 18 Years
Eligible 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

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 + dapagliflozin-matched placebo 		Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
  • Drug: Elecoglipron
    Elecoglipron is administered orally once daily.
  • Drug: Dapagliflozin-matched placebo
    A placebo matching dapagliflozin, administered orally once daily.
Experimental
Elecoglipron dose level 2 + dapagliflozin-matched placebo 		Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.
  • Drug: Elecoglipron
    Elecoglipron is administered orally once daily.
  • Drug: Dapagliflozin-matched placebo
    A placebo matching dapagliflozin, administered orally once daily.
Experimental
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.
  • Drug: Elecoglipron
    Elecoglipron is administered orally once daily.
  • Drug: Dapagliflozin
    Dapagliflozin administered orally once daily.
Placebo Comparator
Elecoglipron-matched placebo + dapagliflozin-matched placebo 		Participants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily.
  • Drug: Elecoglipron-matched placebo
    A placebo matching elecoglipron, administered orally once daily.
  • Drug: Dapagliflozin-matched placebo
    A placebo matching dapagliflozin, 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