A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron and Dapagliflozin in Combination, Compared With Elecoglipron Alone and Dapagliflozin Alone, in Adults With Type 2 Diabetes Mellitus (Eluminate-5)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 2,000
- 试验地点
- 298
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Elecoglipron-matched placebo + dapagliflozin
Participants will receive elecoglipron-matched placebo + dapagliflozin, administered orally once daily.
干预措施: Dapagliflozin (Drug)
Elecoglipron dose level 1 + dapagliflozin-matched placebo
Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
干预措施: 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.
干预措施: Elecoglipron (Drug)
Elecoglipron-matched placebo + dapagliflozin
Participants will receive elecoglipron-matched placebo + dapagliflozin, administered orally once daily.
干预措施: Elecoglipron-matched placebo (Drug)
Elecoglipron dose level 2 + dapagliflozin
Participants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily.
干预措施: 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.
干预措施: Dapagliflozin-matched placebo (Drug)
Elecoglipron dose level 2 + dapagliflozin
Participants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily.
干预措施: Elecoglipron (Drug)
Elecoglipron dose level 1 + dapagliflozin
Participants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily.
干预措施: Elecoglipron (Drug)
Elecoglipron dose level 1 + dapagliflozin
Participants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily.
干预措施: Dapagliflozin (Drug)
Elecoglipron dose level 1 + dapagliflozin-matched placebo
Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
干预措施: Elecoglipron (Drug)