Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes: a Randomized Controlled Parallel Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Percentage of time of glucose levels spent in the target range (empagliflozin vs placebo)
研究概览
简要总结
The goal of this 26-week multicenter, randomized, parallel, placebo-controlled trial is to test the effectiveness of empagliflozin use in conjunction with automated insulin delivery (AID) to improve glucose control in individuals with type 1 diabetes who do not meet target recommendations for time in range (3.9-10.0 mmol/L). The main question it aims to answer is:
- Will use of empagliflozin (2.5 mg/day) increase time spent in the target range of 3.9 to 10.0 mmol/L compared to placebo for individuals on an AID system who do not meet glycemic targets?
Participants will either take 2.5 mg of empagliflozin or a placebo daily for 26 weeks while remaining on their current AID system.
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)
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
- •Individuals ≥ 18 years of age.
- •A clinical diagnosis of type 1 diabetes for at least one year, as per the investigators' clinical judgment (confirmatory C-peptide and antibodies will not be required).
- •Minimum 3-month use of a commercial advanced AID system.
- •Time in range (3.9 to 10.0 mmol/L) < 70% on their personal AID system in the 30 days prior to screening (with minimum 70% time spent in closed-loop mode).
- •Agreement to use a highly effective method of birth control for individuals of child-bearing age and active avoidance of pregnancy during the trial. Child-bearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a disclosed medical condition causing sterility (ex: hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.
排除标准
- •Current or ≤ 2 week use of any anti-hyperglycemic agent other than insulin (such as SGTL2i).
- •Current or ≤ 1 month use of Glucagon-like Peptide 1 (GLP1)-Receptor Agonists.
- •Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids.
- •Planned or ongoing very low carbohydrate diet (< 50g/day).
- •Glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as per CKD-EPI formula with creatinine levels measured within the last 12 months.
- •Use of hydroxyurea.
- •Planned or ongoing pregnancy.
- •Breastfeeding.
- •Ongoing active risk of recurrent genito-urinary infections, as per the clinical judgement of the investigators.
- •Severe hypoglycemic episode within 1 month of screening, defined as an event resulting in seizure, loss of consciousness, or need to present to the emergency department.
- •Diabetic ketoacidosis within 6 months of screening, defined as an event requiring the need to present to medical attention and administration of intravenous insulin.
- •Any serious medical illness likely to interfere with the ability to complete the trial per the judgment of the investigators.
- •Clinically significant retinopathy as judged by the investigator.
- •Recent (< 3 months) acute macrovascular event (ex: acute coronary syndrome or cardiac surgery).
- •Prior serious reaction to SGLT2i.
- •Use of the Medtronic 670G or 770G system in the last 30 days.
- •In the opinion of the investigator, inability to observe the contraindications of the study drugs, or failure to comply to the study protocol or research team's recommendations (e.g., changing pump parameters, ketone measurements).
研究组 & 干预措施
Empagliflozin 2.5 mg daily
Empagliflozin is a sodium/glucose cotransporter 2 inhibitor (SGLT2i) that inhibits glucose reabsorption in the kidney. In this study, a capsule of empagliflozin 2.5 mg will be taken daily in conjunction with the participant's personal automated insulin delivery system for 26 weeks.
干预措施: Empagliflozin (Drug)
Placebo
As a control, a placebo capsule will be taken daily in conjunction with the participant's personal automated insulin delivery system for 26 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of time of glucose levels spent in the target range (empagliflozin vs placebo)
时间窗: 4 weeks
Target range is defined to be between 3.9 and 10.0 mmol/L of placebo on an automated insulin delivery system vs empagliflozin (2.5 mg) on an automated insulin delivery system. Percent measured as per continuous glucose monitor (CGM) data.
次要结局
- Percentage of time spent in the glucose range between 3.9 and 7.8 mmol/L(4 weeks)
- Coefficient of variance of glucose levels(4 weeks)
- Total insulin delivery (overall, basal, and bolus)(4 weeks)
- Percentage of time spent in the glucose range below 3.9 mmol/L and 3.0 mmol/L(4 weeks)
- Percentage of time spent in the glucose range above 10.0 mmol/L and 13.9 mmol/L(4 weeks)
- Mean glucose levels(4 weeks)
- Standard deviation of glucose levels(4 weeks)
- Mean daily carbohydrate intake(4 weeks)
- HbA1c(26 weeks)
- Estimated glomerular filtration rate (eGFR)(26 weeks)
- Lipid profile(26 weeks)
- Brain Natriuretic Peptide (NT-pro-BNP)(26 weeks)
- Liver profile - bilirubin(26 weeks)
- Liver profile - alanine transaminase (ALT) and alkaline phosphatase (ALP)(26 weeks)
- Measurement of body mass: weight and height(26 weeks)
- Waist and hip circumference, and waist-to-hip ratio(26 weeks)
- Heart rate(26 weeks)
- Blood pressure(26 weeks)
- Average scores between interventions based on Diabetes Treatment Satisfaction Questionnaire(26 weeks)
- Average scores between interventions based on Type 1 Diabetes Distress Scale Questionnaire(26 weeks)
- Average scores between interventions based on Hypoglycemic Fear Survey - II(26 weeks)
- Fasting ketone levels(7 days)
研究者
Melissa-Rosina Pasqua
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre