NCT03632759已完成早期 1 期
Targeting Beta Cell Dysfunction in Longstanding T1D
Carla Greenbaum, MD2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年8月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL.
研究概览
简要总结
The purpose of this study is to determine whether 8 weeks of Liraglutide or Golimumab can transiently improve beta cell function in patients with longstanding Type 1 diabetes (T1D) who secrete proinsulin and little/no C-peptide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 3 years from Type 1 diabetes diagnosis
- •Males and females 18-50 years of age, inclusive
- •Peak MMTT stimulated C-peptide <0.017 pmol/mL
- •Proinsulin levels ≥ 2 pM (either fasting or stimulated)
- •Females of child-bearing potential must be willing to use effective birth control for 12 weeks
- •Willing and able to give informed consent for participation
- •HbA1c ≤ 8.5%
排除标准
- •Concurrent use of non-insulin therapies aimed to control hyperglycemia or use within the past 30 days of screening MMTT (V-2).
- •History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies.
- •Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT or AST> 1.5 x the upper limit of age-determined normal (ULN) .
- •Females who are pregnant or lactating.
- •Receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before enrollment.
- •History of other clinically significant autoimmune disease needing chronic therapy with biologics or steroids with the exception of celiac and stable thyroid disease.
- •Current use of any medication known to significantly influence glucose tolerance (e.g. oral steroids, atypical antipsychotics, diphenylhydantoin, niacin).
- •Any medical or psychological condition that in the opinion of the principal investigator would interfere with the safe completion of the trial.
- •For Study A (liraglutide)
- •Any history of pancreatitis or elevated amylase or lipase.
- •Any personal or family history of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC).
- •Any personal or family history of multiple endocrine neoplasia syndrome type
- •Hypersensitivity to liraglutide.
- •Previous treatment with liraglutide.
- •Known history of clinically significant gastroparesis.
- •For Study B (golimumab)
- •Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections.
- •Any history of demyelinating diseases (such as multiple sclerosis), heart failure, or left ventricular dysfunction.
- •Serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C.
- •Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection.
- •Active infection with EBV, defined by real-time PCR.
- •Active infection with CMV, defined by real-time PCR.
- •Any of the following hematologic abnormalities at screening:
- •White blood count <3,000/μL or >14,000/μL
- •Lymphocyte count <500/μL
- •Platelet count <140,000 /μL
- •Hemoglobin <8.5 g/dL
- •Neutrophil count <2,000 cells/μL
- •Receipt of live vaccine (in the 6 weeks before treatment)
研究组 & 干预措施
Liraglutide
Experimental
Participants will receive subcutaneous (SC) liraglutide for 8 weeks
干预措施: Liraglutide (Drug)
Golimumab
Experimental
Participants will receive subcutaneous (SC) golimumab for 8 weeks
干预措施: Golimumab (Drug)
结局指标
主要结局
Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL.
时间窗: 0-to-8 weeks
次要结局
未报告次要终点
研究者
Carla Greenbaum, MD
Director, Diabetes Program
Benaroya Research Institute
研究点 (2)
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