NCT05218915已完成4 期
Effect of Glucagon-like Peptide 1 Receptor Agonist in Combination with Insulin on Glycaemic Variability and Time-in-range in Diabetic Kidney Disease: a Randomised Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Elaine Chow
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Glycemic variability
研究概览
简要总结
To compare GLP-1 RA plus basal insulin (BGLP) versus basal-bolus (BB) insulin regimens on glycemic variability (GV) and time in range (TIR) in diabetes patients CKD stage 3-4
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus diagnosed for at least 6 months
- •Male or female age ≥ 18 years old and ≤ 75 years old.
- •Body mass index between 18 and 40 kg/m2 inclusive
- •HbA1c ≥ 6.5% and ≤ 9.0% at screening
- •Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- •Patients with CKD stage 3 or 4 as defined by estimated glomerular filtration rate between 15-59 ml/min/m2 by the modified Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening
- •Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) and use of pre-specified glucose monitoring devices.
- •In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
- •Written informed consent to participate in the study provided by the patient.
- •Willing and capable of use of a continuous glucose monitor as judged by the investigator
排除标准
- •Type 1 diabetes
- •Currently pregnant, as demonstrated by a positive pregnancy test at screening or planning pregnancy
- •Treatment with GLP-1 RA or insulin degludec in the past three months
- •Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- •Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
- •Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
- •Extensive skin changes/diseases that preclude wearing the CGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
- •Have a known allergy to medical-grade adhesives
- •Known current or recent alcohol or drug abuse
- •Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction in the six months prior to screening
- •Patients on renal replacement therapy or likely require kidney transplant or dialysis during the study period
- •Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
- •An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
研究组 & 干预措施
GLP1-ra plus basal insulin (BGLP)
Experimental
Dulaglutide and insulin degludec in combination with CGM
干预措施: Dulaglutide (Drug)
GLP1-ra plus basal insulin (BGLP)
Experimental
Dulaglutide and insulin degludec in combination with CGM
干预措施: Insulin Degludec (Drug)
GLP1-ra plus basal insulin (BGLP)
Experimental
Dulaglutide and insulin degludec in combination with CGM
干预措施: Continuous glucose monitor (Device)
Basal bolus insulin (BB)
Active Comparator
Insulin aspart/lispro and insulin degludec in combination with CGM
干预措施: Insulin Degludec (Drug)
Basal bolus insulin (BB)
Active Comparator
Insulin aspart/lispro and insulin degludec in combination with CGM
干预措施: Continuous glucose monitor (Device)
结局指标
主要结局
Glycemic variability
时间窗: 16 weeks
% coefficient of variation on blinded CGM
次要结局
- percent time below range(week 16 and 26)
- HbA1c(week 16 and 26)
- Diabetes Treatment Satisfaction(week 16 and 26)
- percent time in range(week 16 and 26)
- percent time above range(week 16 and 26)
- Self monitored glucose profiles(26 weeks)
- Body weight(week 16 and 26)
- Insulin doses(week 16 and 26)
- eGFR(week 16 and 26)
- uACR(week 16 and 26)
- Self reported hypoglycemia(26 weeks)
研究者
Elaine Chow
Clinical Assistant Professor
Chinese University of Hong Kong
研究点 (1)
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