Evaluation of LY900014 in a Medtronic Pump
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour)
研究概览
简要总结
The purpose of this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are delivered by the Medtronic MiniMed 670G System in adults with type 1 diabetes (T1D). The study will consist of two treatment periods of 4 weeks.
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
- Double (Participant, Investigator)
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
- •Participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months
- •Participants must be using an insulin pump with "rapid-acting insulin" for at least 6 months and the same "rapid acting insulin" for at least the past 30 days
- •Participants must have hemoglobin A1c (HbA1c) values ≥6.0% and ≤8.0%
- •Participants must have been using the MiniMed 670G insulin pump for at least the past 90 days
- •Participants must use their Guardian (3) sensor at least an average of 75% of the time and remain in Auto Mode an average of 70% of the time
排除标准
- •Participants must not have had more than 1 emergency treatment for very low blood glucose or any hospitalizations for poor glucose control (very high blood sugar or diabetic ketoacidosis) in the last 6 months
- •Participants must not have significant abnormal accumulation of fat, loss of fat tissue, or scars just under the skin in areas of infusion or have a history of an infection at an infusion site within 90 days prior to screening
- •Participants must not have a total daily insulin dose >100 units
- •Participants must not be receiving any oral or injectable medication intended for the treatment of diabetes other than rapid-acting analog insulin via CSII in the 30 days prior to screening
- •Participants must not have major problems with their heart, kidneys, liver, or have a blood disorder
研究组 & 干预措施
LY900014
Participants received 100 units per milliliter (U/mL) of LY900014 administered via continuous subcutaneous insulin infusion (CSII) by the Medtronic MiniMed 670G insulin pump.
干预措施: LY900014 (Drug)
Insulin Lispro (Humalog)
Participants received 100 U/mL of Insulin lispro (Humalog) administered via CSII by the Medtronic MiniMed 670G insulin pump.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour)
时间窗: Week 2 through Week 4
Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with baseline, period, sequence, strata (Hemoglobin A1c (HbA1c) \[\<=7.0%, \>7.0%\] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization \[\<=75%, \>75%\]), treatment (Type III sum of squares) as fixed factors.
次要结局
- Mean Sensor Glucose Value (24-Hour)(Week 2 through Week 4)
- Percentage of Time Spent in Auto Mode(Week 2 through Week 4)
- Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour)(Week 2 through Week 4)
- Rate of Severe Hypoglycemic Events(Week 2 through Week 4)
- Total Daily Insulin Dose(Week 2 through Week 4)