JPRN-jRCT2031210019进行中（未招募）3 期
A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Two Doses of Dulaglutide in Combination with a Single Oral Antihyperglycemic Medication or as Monotherapy in Japanese Patients with Type 2 Diabetes Mellitus(AWARD-JPN : Assessment of Weekly AdministRation of LY2189265 in Diabetes - JAPAN) - H9X-JE-GBGQ
Masaki Takeshi0 个研究点目标入组 585 人开始时间: 2021年4月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 585
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants with type 2 diabetes (T2D) for 6 months or more according to the World Health Organization (WHO) classification.
- •-Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.
- •-Have the following HbA1c result at screening.
- •-Participants taking DPP-4i: between 7.5% to 9.5%,
- •-Participants taking another OAM: between 8.0% to 10.0%
- •-Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks
- •-Have a body mass index (BMI) equal to or more than 18.5 kilogram/square meter (kg/m2) and less than 35 kg/m2 at Day 1.
排除标准
- •-Have type 1 diabetes (T1D)
- •-Have a history of >=1 episode of ketoacidosis or hypersmolar state/coma
- •-Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)
- •-Have a known clinically significant gastric empty abnormality
- •-Have acute or chronic hepatitis
- •-Have had chronic or acute pancreatitis
- •-Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia
- •-Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
- •-Have evidence of significant, active autoimmune abnormality
- •-Have evidence of significant, uncontrolled endocrine abnormality
- •-Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
- •-Have any hematologic condition that may interfere with HbA1c measurement
研究者
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