A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 900
- 试验地点
- 206
研究概览
简要总结
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).
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 for at least 90 days prior to screening
- •On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)
- •HbA1c value:
- •On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
- •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
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 dose level 1
Participants will receive elecoglipron at dose level 1, administered orally once daily, in addition to background dapagliflozin 10 mg.
干预措施: Elecoglipron (Drug)
Placebo
Participants will receive placebo administered orally once daily in addition to background dapagliflozin 10 mg.
干预措施: Placebo (Drug)
Elecoglipron dose level 2
Participants will receive elecoglipron at dose level 2, administered orally once daily, in addition to background dapagliflozin 10 mg.
干预措施: Elecoglipron (Drug)