NCT05296044Unknown3 期
This Study Evaluates the Addition of Dapagliflozin in the Treatment of Type 2 Diates With Metformin and JT-003 Combination Therapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Changes in HbA1c
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of JT-003 Add-on in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin and Dapagliflozin
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older with type 2 diabetes mellitus
- •Subjects with 7.0% ≤ HbA1c ≤ 11% at baseline
- •Those with > 45 kg/m2 of BMI
- •Those who voluntarily signed the informed consent to participate in this study
排除标准
- •Those who had allergic reaction to main ingredients or components of the investigational products.
- •Patients with the following major systemic disease
- •Patients with type 1 diabetes mellitus, secondary diabetes, or congenital renal diabetes etc.)
- •Patients with pituitary insufficiency or adrenal dysfunction
- •Patients with uncontrolled glycosemia(FPG > 270 mg/dL)
- •Patients with uncontrolled hypertension(SBP > 180 mmHg or DBP > 110 mmHg
- •Patients with severe hypertriglyceridemia (Triglyceride > 500 mg/dL)
- •Patients with severe renal dysfunction
- •Patients with liver dysfunction
- •Patients with AIDS
- •Those with clinically significant severe infection or trauma based on an investigator's judgement
- •Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia
- •Unstable mental illness not regulated by drugs
- •Those who suffered from gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of investigational products or had underwent surgery;
- •Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
- •Those with a history of malignant tumor within 5 years
- •Those with history of alcohol or drug abuse within 1 years
- •Those with heart failure (NYHA class II~IV) or who had suffered from heart failure within 6 months
- •Those who underwent surgery requiring general anesthesia within 4 weeks as of Visit 1 or who are scheduled to receive such surgery within 4 weeks after the study ends
- •Those who need to take prohibited concomitant medications stated during the study period.
- •Females who are pregnant or breastfeeding or patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
- •Those who are judged unsuitable for the study by a principal investigator or investigators
- •Those who have been administered with the following drugs or expected to require the continued administration during the study period:
- •Those who have been administered with obesity drugs within 12 weeks
- •Those being administered with thyroid medications and whose dose has been modified within 6 weeks
- •Those administered with systemic steroid agents (Prednisolone, >30 mg/day) within 2 weeks
- •Those being administered with diuretics and whose dose has been modified within 8 weeks as (however, dose reduction is accepted.)
- •Those who are currently participating in other ongoing clinical studies or those who have taken the investigational products from other clinical studies within 12 weeks
研究组 & 干预措施
JT-003
Experimental
Drug: JT-003
干预措施: JT-003 (Drug)
JT-003 Placebo
Placebo Comparator
Drug: JT-003 Placebo
干预措施: JT-003 Placebo (Drug)
结局指标
主要结局
Changes in HbA1c
时间窗: 24 week from the baseline
Changes in HbA1c at the 24 week from the baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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