Phase 1 Study of Medtronic Closed Loop Device With ePID Algorithm and Enlite Sensors on Adjuvant Therapy With Insulin and Liraglutide to Minimize Post-prandial Hyperglycemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone
研究概览
简要总结
Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic excursions than insulin mono-therapy.
Specific Aim: To determine if post-prandial glucose excursions are lowered with the addition of Liraglutide compared to insulin mono-therapy.
Study Design: This is a randomized open labeled crossover design trial comparing adjuvant Liraglutide and insulin Vs. insulin mono-therapy using the ePID closed-loop system for insulin delivery.
详细描述
After the screening visit, subjects will be randomized to come for two overnight visits. Study A- the subjects will be on the closed loop device with Novolog rapid acting insulin. In Study B- in addition to insulin the subjects will take a one time sub cutaneous injection of 1.2 mg of Victoza before dinner on Day 1. Both visits will last for approximately 30 hours and the subjects will be managed by the closed loop device for approximately 25 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years and less than 40 years
- •Have had diabetes for at least 1 year, and in good control (HbA1C < 8.5 %)
- •Be on continuous subcutaneous insulin infusion using an insulin pump
- •Menstruating women must have negative pregnancy test.
- •Hemoglobin (Hb) > 12 g/dL
- •Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 3 months prior to Screening:
- •a. Oral contraceptives (female subjects)b. Antihypertensive agents c. Lipid-lowering agents d. Thyroid replacement therapy e. Antidepressant agents
- •For female subjects:a. Not breastfeeding b. Negative pregnancy test result (human chorionic gonadotropin, beta subunit [βhCG])at Screening c. If of childbearing potential, must practice and be willing to continue to practice appropriate birth control (defined as at least one method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectable's, hormonal contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation or occlusion, or a vasectomized partner)during the entire duration of the study and must not be planning to conceive
- •Should not have any alcohol or drug dependency as assessed by CRAFFT questionnaire.
排除标准
- •Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc., that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis
- •Hemoglobin less than 12 g/dl
- •Positive pregnancy test in menstruating young women
- •Evidence or history of chemical abuse
- •HbA1c > 8.5 %
- •Weight less than 50 Kg
- •History of gastro paresis and on medications that alter gastric emptying
- •History of Pancreatitis and impaired renal function
- •Hypoglycemic unawareness
- •History of sensitivity to 5-HT3 receptor antagonists
- •History of QT prolongation or any known cardio-vascular disease
- •Concomitant use of both Acetaminophen and vitamin C
- •Patients on glucocorticoid therapy
- •Known allergy to Liraglutide
- •Personal or family history of elevated calcitonin, calcitonin >100 ng/L, medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia (MEN) syndrome type 2.
研究组 & 干预措施
Closed loop with sensor and Insulin
subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone.
干预措施: Closed loop with sensor and Insulin (Drug)
Closed loop with sensor, Insulin and Liraglutide
Subject will be on the closed loop device with enlite sensors for about 27 hours. In addition to being on insulin, they would take a single injection of 1.2 mg of Liraglutide subcutaneously before dinner, on Day 1.
干预措施: Closed loop with sensor, Insulin and Liraglutide (Drug)
结局指标
主要结局
Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone
时间窗: 0-1500 min
Measure of targeted blood glucose levels in the Closed Loop setting in the treatment arm, with the addition of Liraglutide compared to insulin monotherapy (continuous subcutaneous insulin infusion)
次要结局
未报告次要终点
研究者
Rubina Heptulla
Division Chief of Pediatric Endocrinology
Albert Einstein College of Medicine