A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 795
- 试验地点
- 70
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis]
研究概览
简要总结
The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.
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
盲法说明
Sponsor will be blinded throughout the study.
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 diagnosis of T2D according to the World Health Organization criteria.
- •Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.
- •Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.
- •Are insulin naive
- •Exceptions:
- •short-term insulin treatment for a maximum of 14 days, prior to screening, and
- •prior insulin treatment for gestational diabetes.
排除标准
- •Have a diagnosis of type 1 diabetes (T1D), latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
- •Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
- •Have had severe hypoglycemia episodes within 6 months prior to screening.
- •Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
- •Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
- •acute myocardial infarction
- •cerebrovascular accident (stroke), or
- •coronary bypass surgery.
- •Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
- •Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.
研究组 & 干预措施
Insulin Efsitora Alfa
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
干预措施: Insulin Efsitora Alfa (Drug)
Insulin Glargine
Participants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis]
时间窗: Baseline, Week 52
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.
次要结局
- Change From Baseline in HbA1c [Superiority](Baseline, Week 52)
- Change From Baseline in Fasting Glucose(Baseline, Week 52)
- Basal Insulin Dose at Week 52(Week 52)
- Rate Per Year of Hypoglycemia Events(Baseline up to Week 52)
- Percentage of Participants With Hypoglycemia Events (Incidence)(Week 52)
- Rate Per Year of Nocturnal Hypoglycemia Events(Baseline up to Week 52)
- Percentage of Participants With Nocturnal Hypoglycemia Events (Incidence)(Week 52)
- Change From Baseline in Body Weight(Baseline, Week 52)
- Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Total Score(Baseline, Week 52)
- Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c)(Baseline, Week 52)
- Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version(Week 52)
- Change From Baseline in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics(Baseline, Week 52)
- Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)(Week 52)