A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 628
- 试验地点
- 41
- 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 2 diabetes (T2D).
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 T2D based on the disease diagnostic criteria World Health Organization (WHO) classification.
- •Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily.
- •Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs).
- •Participants must have a HbA1c ≥7.0% and ≤11.0%.
- •Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).
排除标准
- •Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults.
- •Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening.
- •Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
- •Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
研究组 & 干预措施
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
Participants received 100 U/mL insulin lispro (Humalog) given 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
Participants received 100 U/mL insulin lispro (Humalog) given 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)
Insulin Lispro
Participants received 100 U/mL insulin lispro (Humalog) given 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. 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 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).
次要结局
- 2-hour PPG Excursion During MMTT(Week 26)
- Percentage of Participants With HbA1c <7% and ≤6.5%(Week 26)
- 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)(Week 26)
- Rate of Documented Symptomatic Postmeal Hypoglycemia(Baseline through Week 26)
- Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)(Baseline, Week 26)
- Change From Baseline in Insulin Dose(Baseline, Week 26)
- Rate of Severe Hypoglycemia(Baseline through Week 26)
- Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values(Baseline, Week 26)