A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 30
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants 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
- •Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
- •Participants must have HbA1c of ≥7.0 and ≤10.0%.
- •Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily.
- •Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter (kg/m2).
排除标准
- •Participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days prior to screening.
- •Participants must not have had more than 1 severe hypoglycemic episode within 6 months prior to screening.
- •Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months prior to screening.
研究组 & 干预措施
Insulin Lispro (Humalog)
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
干预措施: Insulin Lispro (Drug)
Insulin Lispro (Humalog)
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
干预措施: Insulin Glargine (Drug)
LY900014
Participants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
干预措施: LY900014 (Drug)
LY900014
Participants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
干预措施: Insulin Glargine (Drug)
LY900014
Participants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
干预措施: Insulin Degludec (Drug)
Insulin Lispro (Humalog)
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
干预措施: Insulin Degludec (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. It 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 Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
次要结局
- Rate of Documented Symptomatic Post Meal Hypoglycemia(Baseline through Week 26)
- Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values(Baseline, Week 26)
- Percentage of Participants With HbA1c <7% and ≤6.5%(Week 26)
- 2-hour PPG Excursion During MMTT(Week 26)
- 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)(Week 26)
- Rate of Severe Hypoglycemia(Baseline through Week 26)
- Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)(Baseline, Week 26)
- Change From Baseline in Daily Insulin Dose(Baseline, Week 26)