NCT07222332招募中3 期
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 245
- 主要终点
- Change from Baseline in C-peptide Area Under the Curve (AUC)
研究概览
简要总结
The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.
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
- 1 Year 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention
- •Have at least one diabetes-related autoantibody found at screening
- •Show signs of remaining beta-cell function
- •stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening
- •Weigh at least 8 kilograms (kg) (18 pounds) at screening
排除标准
- •Have any other type of diabetes including gestational
- •Have uncontrolled high blood pressure
- •Have had a heart attack, heart disease, stroke, or heart failure
- •Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy
- •Have a current or recent clinically serious medical condition or infection
研究组 & 干预措施
Baricitinib
Experimental
Participants will receive baricitinib orally
干预措施: Baricitinib (Drug)
Placebo
Placebo Comparator
Participants will receive placebo orally
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in C-peptide Area Under the Curve (AUC)
时间窗: Baseline, Week 52
次要结局
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 52)
- Change from Baseline in Number of Manual Insulin Boluses(Baseline, Week 52)
- Rate of Clinically Significant Hypoglycemic Events(Baseline through Week 52)
- Change from Baseline in Fasting C-Peptide(Baseline, Week 52)
- Change from Baseline in Height(Baseline, Week 52)
- Change from Baseline in Mean Total Daily Insulin Dose(Baseline, Week 52)
- Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)(Baseline, Week 52)
- Change from Baseline in Matsuda Index(Baseline, Week 52)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib(Predose through Week 16)
研究者
研究点 (245)
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