NCT06042153进行中（未招募）4 期
Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 5
- 主要终点
- Change in TIR (70-180 mg/dl)
研究概览
简要总结
This study will look at control of blood sugar levels in persons with type 2 diabetes mellitus currently on chronic dialysis. Researchers will compare blood sugar levels in people taking semaglutide to people taking "dummy" medicine. The treatment participants get will be decided randomly.
Participants will need to inject the study medication once a week. The study will last for 1 year and a month. Participants will be asked to wear a sensor that measures blood sugar levels for a period of 10 days at five different time points during the study.
详细描述
The researchers also have a Data Safety Monitoring Plan in place.
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
The randomization and each dispensation will be performed by blinded study staff using an electronic system coded with the randomization code, to ensure all study personnel remains blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedures that are carried out as a part of trial, including activities to determine suitability for the trial.
- •Male or female Adults (age > 18 years at the time of signing the consent)
- •Type 2 diabetes mellitus diagnosed > 6 months prior to screening
- •On current chronic treatment with Hemodialysis or Peritoneal dialysis for > 6 months prior to screening
- •Current treatment with any glucose lowering pharmacotherapy, at a stable dose for at least 30 days. DPP-4 Inhibitors will be allowed at study entry and will be stopped at randomization.
- •Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download
- •Time in Range 15 to 60%
排除标准
- •BMI < 23 kg/m2 at screening
- •Current (within the past 90 days of screening) use of any GLP-1 RA
- •Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2
- •Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or related products)
- •Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures
- •Active weight loss, defined as weight loss of >5% of body weight in the past 3 months
- •Current participation in other interventional trials or last dose of any investigational product within 4 half- lives at the time of randomization
- •Any medical condition which in the judgement of the investigator precludes safe participation in the trial (includes, but not limited to active neoplasm, severe heart failure, recent cardiovascular event, severe frailty, planned cardiac or vascular surgeries on the day of screening etc)
- •If weight loss is not desired by the participant, or if the provider or investigator considers intentional weight loss to be detrimental to the health of the participant
- •Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes mellitus, MODY, LADA, drug induced, etc.)
- •Current diagnosis of gastroparesis or enteropathywhich in the opinion of investigator precludes safe treatment with GLP-1 RA.
- •Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in the opinion of the investigator)
- •Personal history of chronic pancreatitis, or acute pancreatitis within 180 days of screening
- •Known current uncontrolled or unstable retinopathy (by medical history)
研究组 & 干预措施
Arm 1 - Semaglutide
Experimental
Participants will receive semaglutide as an adjunct to standard-of-care.
干预措施: Semaglutide (Drug)
Arm 2- Placebo
Placebo Comparator
Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in TIR (70-180 mg/dl)
时间窗: Baseline, 52 weeks
Measured in percentage by Continuous glucose monitor (CGM)
次要结局
- Change in haemoglobin A1c (HbA1c)(Baseline, 52 weeks)
- Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline(52 weeks)
- Change in waist circumference(Baseline, 52 weeks)
- Change in percentage total body fat(Baseline, 52 weeks)
- Change in percentage lean mass(Baseline, 52 weeks)
- Total score of EQ-5D-5L(52 weeks)
- Proportion of participants with Time below range <70 mg/dL for <4% of each day(52 weeks)
- Proportion of participants with >10 points improvement in % TIR 70-180 mg/dL without an increase in time below range <54 mg/dL of >0.5%(52 weeks)
- Proportion of participants with Time below range <54 mg/dL for <1% of each day(52 weeks)
- Number of participants with Severe hypoglycemia(52 weeks)
- Number of participants hospitalized(52 weeks)
- Total number of days spent in hospital(52 weeks)
- Total score of Diabetes Treatment Satisfaction questionnaire(52 weeks)
- Total daily dose of insulin(52 weeks)
- Change in body weight(Baseline, 52 weeks)
- Total score of Kidney disease QoL short form(52 weeks)
- Change in Time in high range (180-250 mg/dl)(Baseline, 52 weeks)
- Change in Time in very high range (>250 mg/dl)(Baseline, 52 weeks)
- Change in Time in low range (54-69 mg/dl)(Baseline, 52 weeks)
- Change in Time in very low range (<54 mg/dl)(Baseline, 52 weeks)
- Proportion of participants with TIR 70-180 mg/dl for 70% of the day(52 weeks)
- Proportion of participants with Time above range >180 mg/dL for <25% of each day(52 weeks)
- Number of oral glucose lowering agents(52 weeks)
- Proportion of participants with mean glucose <154 mg/dL and <1% time below range <54 mg/dL(52 weeks)
- Change in Inter-dialysis weight gain(Baseline, 52 weeks)
研究者
Ildiko Lingvay
Professor
University of Texas Southwestern Medical Center
研究点 (5)
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