JPRN-jRCT2031230337招募中3 期
A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J) - J2A-JE-GZPE
Masaki Takeshi0 个研究点目标入组 399 人开始时间: 2023年9月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 399
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable(—)
- 性别
- All
入选标准
- •Have Type 2 Diabetes (T2D)
- •Have HbA1c >=7.0% (>=53 mmol/mol) to <=10.5% (<=91 mmol/mol) as determined by the central laboratory at screening.
- •Are of stable weight (+-5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
- •Have a BMI >=23.0 kilogram/square meter (kg/m2) at screening.
排除标准
- •Have Type 1 Diabetes (T1D).
- •Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.
- •Have New York Heart Association functional classification IV congestive heart failure.
- •Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.
- •acute myocardial infarction
- •cerebrovascular accident (stroke), or
- •hospitalization for congestive heart failure
- •Have acute or chronic hepatitis and pancreatitis
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