NCT05847413已完成早期 1 期
Targeting Beta Cell Dysfunction With Verapamil in Longstanding T1D
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL at 12 weeks.
研究概览
简要总结
The purpose of this study is to determine whether verapamil can transiently improve beta cell function in those who do or do not secrete proinsulin and little/no C-peptide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •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 initial qualifying MMTT (V-2).
- •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).
- •Renal disease, as defined by creatinine ≥1.5 mg/dL.
- •Hypersensitivity to verapamil or any component of the formulation.
- •Previous use of verapamil.
- •Known left ventricular dysfunction; bradycardia (HR <50 BPM) hypotension (systolic pressure <90 mm Hg); PR interval prolongation on EKG or any bradyarrhythmia (e.g. sick sinus syndrome, Anterior Ventral (AV) block); atrial flutter or fibrillation, and an accessory bypass tract (Wolff- Parkinson- White (WPW) syndrome, Lown-Ganong-Levine syndrome)
- •Uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease or other serious cardiac disease as described in New York Heart Association (NYHA) Class III or IV criteria within the 12 weeks before randomization.
- •Use of beta blockers or medium-high dose statins: any dose of atorvastatin (Lipitor) or rosuvastatin (Crestor); simvastatin > 10 mg daily; lovastatin > 20 mg; pravastatin > 20 mg
- •Use of other medications which may increase the concurrent risk of verapamil use, including medications which utilize the cytochrome p450 enzyme pathway.
- •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 except for 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. Conditions to consider include history of chronic GERD, chronic constipation, and chronic nausea.
- •Specific to MRI subjects: non-removable ferromagnetic materials or MRI not technically feasible (claustrophobia, movement disorder, obesity).
研究组 & 干预措施
Targeting Beta cell Dysfunction with Verapamil in Longstanding T1D
Experimental
Participants will receive verapamil for 12 weeks
干预措施: Verapamil (Drug)
结局指标
主要结局
Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL at 12 weeks.
时间窗: 0-12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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