A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 79
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16
研究概览
简要总结
The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).
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
- 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
- •Have been diagnosed with T1D and continuously using insulin for at least 1 year
- •Have been using CSII therapy for a minimum of 6 months
- •Currently treated with <100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine
- •Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days
排除标准
- •Have hypoglycemia unawareness
- •Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
- •Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
研究组 & 干预措施
Insulin Lispro (Humalog)
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
干预措施: Insulin Lispro (Drug)
Ultra-Rapid Lispro
Participants received individual dose of 100 units per milliliter (U/mL) ultra rapid lispro by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
干预措施: Ultra-Rapid Lispro (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16
时间窗: Baseline, Week 16
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
次要结局
- Rate of Severe Hypoglycemia at Week 16(Baseline through Week 16)
- Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16(Baseline, Week 16)
- Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16(Baseline, Week 16)
- Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16(Week 16)
- Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16(Baseline, Week 16)
- Change From Baseline in Insulin Dose at Week 16(Baseline, Week 16)
- Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change(Baseline through Week 16)
- Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia >300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change(Baseline through Week 16)
- Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16(Baseline, Week 16)
- Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16(Baseline, Week 16)
- Rate of Documented Symptomatic Hypoglycemia at Week 16(Baseline through Week 16)
- Percentage of Participants With HbA1c <7%(Week 16)