A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 692
- 试验地点
- 82
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Noninferiority Analysis]
研究概览
简要总结
The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.
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
- None
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 a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
- •Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
- •Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
- •Have a body mass index of ≤35 kilogram/square meter (kg/m²)
排除标准
- •Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
- •Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
- •Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.
研究组 & 干预措施
Insulin Efsitora Alfa
Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 units per milliliter (U/mL) Insulin Lispro) received 500 U/mL of insulin efsitora alfa administered once weekly (QW) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up.
干预措施: Insulin Efsitora Alfa (Drug)
Insulin Degludec
Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 U/mL Insulin Lispro) received 100 U/mL of Insulin Degludec administered once daily (QD) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up.
干预措施: Insulin Degludec (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Noninferiority Analysis]
时间窗: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with treatment + country + CGM use prior to study entry \[yes/no\]+ carbohydrate counting for prandial insulin\[yes/no\] + baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach.
次要结局
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Superiority Analysis](Baseline, Week 26)
- Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 23 to Week 26(Week 23 to Week 26)
- Nocturnal Hypoglycemia Event Rate(Baseline up to Week 52)
- Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis](Baseline, Week 52)
- Change From Baseline in Fasting Blood Glucose(Baseline, Week 26, and Week 52)
- Glucose Variability(Week 23 to Week 26 and Week 49 to Week 52)
- Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 49 to Week 52(Week 49 to Week 52)
- Basal Insulin Dose(Week 26 and Week 52)
- Bolus Insulin Dose(Week 26 and Week 52)
- Total Insulin Dose(Week 26 and Week 52)
- Basal Insulin Dose to Total Insulin Dose Ratio(Week 26 and Week 52)
- Hypoglycemia Event Rate(Baseline up to Week 52)
- Change From Baseline in Body Weight(Baseline, Week 26, and Week 52)
- Percentage of Time in Hypoglycemia Range With Blood Glucose <54 mg/dL (3.0 mmol/L)(Week 23 to Week 26 and Week 49 to Week 52)
- Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L) From Week 23 to Week 26(Week 23 to Week 26)
- Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L) From Week 49 to Week 52(Week 49 to Week 52)
- Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) at Week 26(Week 26)
- Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) at Week 52(Week 52)
- Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form (Physical-Component and Mental-Component) Scores(Baseline, Week 26, and Week 52)