跳至主要内容
临床试验/jRCT2031230325
jRCT2031230325进行中(未招募)不适用

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (J2A-MC-GZGT)

Eli Lilly Japan K.K.0 个研究点目标入组 520 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
520
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Double Blind

入排标准

年龄范围
18age old over 至 No limit(—)
性别
All

入选标准

  • Have Type 2 Diabetes
  • Have HbA1c >=7.0% (53 mmol/mol) to <=9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
  • Are naive to insulin therapy except for gestational diabetes or <=14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
  • 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 body mass index (BMI) >=23.0 kilogram/square meter (kg/m2) at screening.

排除标准

  • Have Type 1 Diabetes
  • Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
  • Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
  • Have New York Heart Association functional classification IV congestive heart failure.
  • Have acute or chronic hepatitis

结局指标

主要结局

-

Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Week 40 ]

次要结局

未报告次要终点

研究者

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