NCT07186660招募中2 期
Evaluation of a Novel Insulin Sensitizer on Glycemic Control, Insulin Usage, and Cardiovascular Biomarkers in People With Type 1 Diabetes Who Use Closed-loop Automated Insulin Delivery
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Glucose Time-in-Range
研究概览
简要总结
The purpose of this study is to see if the study drug CIR-0602K will improve glucose time-in-range and/or lower total daily insulin dose in people with type 1 diabetes who are using closed-loop automated insulin delivery. Researchers will compare CIR-0602K to a placebo (a look-alike substance that contains no drug) to see if it achieves the investigational endpoints. If the study results show that the drug works to increase time-in-range and lower insulin doses, this will lead to further studies which may then make the drug available to the public.
详细描述
Participants in the study will:
- Come to the Clinical Research Unit (CRU) at UVA Medical Center for 3 visits: Screening, Baseline (Admission 1) and End-of-Study (Admission 2).
- Complete various tests of cardiovascular health at each visit.
- Take either an experimental drug (CIR-0602K) or placebo for 12 weeks.
- Wear a study CGM with their personal insulin pump for 12 weeks.
- Be given a ketone meter and strips and be asked to take a fingerstick ketone reading every morning for 12 weeks.
- The study team will contact the participants regularly during the study to check their health and how they are tolerating the study drug/placebo.
- Return the study CGM, ketone meter, and remaining supplies, etc. at the end of the study.
- Notify the study team of any illness, injury, hypoglycemic or hyperglycemic events during the study
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)
盲法说明
Clinical research team
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •History of type 1 diabetes for at least one year
- •Age 18-45 years
- •HbA1c <10%
- •BMI 18-35 kg/m
- •Within this criterion, participants must have either BMI ≥25 or total daily insulin dose of ≥0.5 units/kg/day.
- •Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM.
- •On stable regimen of non-diabetic medications for the last 6 months.
- •All screening labs within normal limits or not clinically significant.
- •Ability to take oral medication and be willing to adhere to the study drug/placebo for 12 weeks.
- •For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 2 weeks after the end of CIR-0602K administration.
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study intervention.
- •Agreement to adhere to Lifestyle Considerations throughout study duration.
排除标准
- •Current Pregnancy or currently breastfeeding.
- •History of smoking tobacco products within the last two years.
- •History of alcohol abuse or illicit drug abuse within 6 months of screening.
- •Known history of human immunodeficiency virus (HIV).
- •History of other significant disease (e.g., cardiac, cerebrovascular, gastrointestinal, liver, renal, or endocrine) that could, in the investigator's view, alter study outcomes
- •Any surgical or medical condition which may significantly alter the absorption of the study drug including but not limited to the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome.
- •Current use of any antihyperglycemic medication beyond insulin (i.e., GLP-1 receptor agonists, SGLT2 inhibitors, etc.).
- •Unstable doses (i.e., dose change within the last 4 months) of vasoactive medications (e.g., calcium-channel blockers, statins, angiotensin-converting enzyme inhibitors, diuretics, nitrates, alpha-blockers, beta-blockers, etc.).
- •Daily use of anti-inflammatory medications (e.g., ibuprofen, aspirin, prednisone, dexamethasone, etc.).
- •Diagnosis of peripheral neuropathy (assessed by screening monofilament exam).
- •Macroalbuminuria (i.e., urine albumin: creatinine >300 mg per g).
- •Retinopathy beyond mild, nonproliferative retinopathy.
- •History of Level 3 hypoglycemia within the last 12 months.
- •History of diabetic ketoacidosis (DKA) within the last 12 months.
- •Screening electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease.
- •Screening oxygen saturation <90%
- •History of hypersensitivity or prior adverse reaction to the study drug, closely-related compounds, or any of the stated ingredients.
- •Use of concomitant medications with a known significant metabolism by CYP2C8 or CYP2C (including paclitaxel, phenytoin, warfarin, celecoxib, tolbutamide, or repaglinide) for the duration of the study.
- •Participation in an investigational study (other than a non-treatment registry study) or received an investigational drug withing 30 days or 5 half-lives (whichever is longer) prior to randomization.
研究组 & 干预措施
CIR-0602K
Active Comparator
CIR-0602K 250 mg daily
干预措施: CIR-0602K (Drug)
Placebo
Placebo Comparator
Matching Placebo Tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Glucose Time-in-Range
时间窗: 12 weeks
Glucose time 70-180 mg/dL
次要结局
- Glucose Time-above-Range(12 weeks)
- Glucose Time-Below-Range(12 weeks)
- Hemoglobin A1c(12 weeks)
- Total Daily Insulin Dose(12 weeks)
- Insulin Sensitivity(12 weeks)
研究者
William Horton, MD
Associate Professor
University of Virginia
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime InsulinType 1 Diabetes MellitusNCT01658579Sanofi59
终止
4 期
Rosiglitazone Versus Placebo in Chronic Stable AnginaMetabolic Syndrome XAngina PectorisNCT00225355University of Glasgow80
已完成
3 期
A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT05813912Novo Nordisk A/S148
撤回
不适用
A New Wizard for Insulin Sensitivity Estimation From SAP: a Randomized Controlled Trial in Adolescents With T1DDiabetes MellitusNCT03034759Yale University
已完成
4 期
Tarka vs. Hyzaar in Patients With Metabolic Syndrome (STAR)Metabolic SyndromeHypertensionNCT00234858Abbott280