NCT07664553招募中3 期
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 on Background Insulin (Eluminate-3)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 600
- 试验地点
- 252
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), treated with a background insulin and other background 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 T2DM for at least 90 days prior to screening
- •Stable treatment with background insulin and other background glucose-lowering medication(s)
- •HbA1c value of ≥ 7% to ≤ 10.5%
- •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
- •T1DM, 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 (NYHA IV)
- •History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
研究组 & 干预措施
Elecoglipron dose level 2
Experimental
Participants will receive elecoglipron at dose level 2 administered orally once daily.
干预措施: Elecoglipron (Drug)
Placebo
Placebo Comparator
Participants will receive placebo administered orally once daily.
干预措施: Placebo (Drug)
Elecoglipron dose level 1
Experimental
Participants will receive elecoglipron at dose level 1 administered orally once daily.
干预措施: Elecoglipron (Drug)
研究者
研究点 (252)
Loading locations...
相似试验
招募中
3 期
A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT07662213AstraZeneca1,200
招募中
3 期
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 DapagliflozinType 2 Diabetes With Chronic Kidney DiseaseType 2 Diabetes MellitusNCT07662135AstraZeneca900
招募中
3 期
A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT07662109AstraZeneca2,000
招募中
3 期
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 MellitusType 2 Diabetes MellitusNCT07662044AstraZeneca800
进行中（未招募）
1 期
A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy ParticipantsHealthy ParticipantsNCT07534592AstraZeneca48