NCT05466643招募中3 期
A Multicenter, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 as add-on Therapy to Drug A, With or Without Antihyperglycemic Drugs, in Patients With Type 2 Diabetes Mellitus
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年3月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Changes from Baseline HbA1c
研究概览
简要总结
A multicenter, randomized, placebo-controlled clinical trial, double-blind, parallel-group
详细描述
Phase 3 study in patients with T2DM, who have inadequate glycemic control on Drug A alone or Drug A in combination with antihyperglycemic drugs.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥19 and ≤ 80 years of age at Visit 1 (Screening) in accordance with American Diabetes Association (ADA) guidelines
- •Patients who had received a stable dose of Drug A for at least 8 weeks prior to Visit 2 (Run-in vis it).
- •In case of antidiabetic concomitant medications, patients who have maintained up to 2 oral antidiabetic drugs [OADs]) without changing regimen/dose/dosage at least 8 weeks prior to Visit 2 (Run-in visit).
- •Patients with FPG of <270 mg/dL at Visit 1 (Screening) (FPG result at Visit 1 will use local laboratory results)
- •Body Mass Index (BMI) 18.0-40.0 kg/m2.
排除标准
- •Patients with type 1 diabetes mellitus (T1DM), congenital diabetes mellitus (DM), or secondary diabetes as follows:
- •Diabetes caused by Cushing's syndrome and acromegaly.
- •Patients with fasting C-peptide <0.70 ng/mL (0.23 nmol/L) are excluded if the Investigator cannot rule out T1DM based on the clinical assessment.
- •Patients with a history of T1DM or a history of ketoacidosis or patients assessed by the Investigator as possibly having T1DM confirmed with a C-peptide <0.70 ng/mL (0.23 nmol/L).
- •History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
- •Patients receiving SGLT2 inhibitors, GLP-analogues, thiazolidinediones, or sulfonylureas (at Screening and Run in).
- •At Visit 1 (Screening), patients with a history of the following:
- •Patients who had experienced severe hypoglycemia within 24 weeks prior to Screening or who had experienced hypoglycemia at least 3 times a week within 8 weeks prior to Screening.
- •Patients with a history of diabetic ketoacidosis or coma from hyperosmolar hyperglycemic syndrome within 24 weeks.
- •Patients with a history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, within 3 months prior to Screening.
- •Patients with New York Heart Association (NYHA) Class III, IV congestive heart failure or arrhythmia requiring treatment. History of dose modification of a treatment for thyroid dysfunction within the past 6 weeks (If patients have been on a stable dose from before enrollment to the study, concomitant administration is allowed. Dose reduction for stable condition is allowed).
- •Patients who had a surgical operation within 4 weeks (excluding minor surgeries without restriction on food and fluid intake) or who are scheduled to have a significant surgery during the study period.
- •Patients with pituitary insufficiency or adrenal insufficiency.
- •Patients with pulmonary embolism, severe pulmonary dysfunction, or who are susceptible to be accompanied by hypoxemia at Screening.
- •Patients who are on or likely to require treatment for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
研究组 & 干预措施
DWP16001
Experimental
干预措施: DWP16001 0.3mg (Drug)
Placebo
Placebo Comparator
干预措施: DWP16001 Placebo (Drug)
结局指标
主要结局
Changes from Baseline HbA1c
时间窗: at Week 24
次要结局
未报告次要终点
研究者
研究点 (1)
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