A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 730
- 试验地点
- 80
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]
研究概览
简要总结
The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.
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 diagnosis of T2D according to the world health organization (WHO) criteria, currently treated with basal insulin and at least 2 injections of prandial insulin per day.
- •Are receiving ≥10 units of total basal insulin per day at screening.
- •Are receiving ≤2 units/kilogram/day of total daily insulin at screening
- •Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening
- •Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening
- •once daily U-100 or U-200 insulin degludec
- •once daily U-100 or U-300 insulin glargine
- •once or twice daily U-100 insulin detemir or
- •once or twice daily human insulin Neutral Protamine Hagedorn
- •Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur at the evening meal.
- •Insulin lispro-aabc
- •Insulin lispro (U-100 and U-200)s, IN], U-100 or U200)
- •Insulin aspart (U-100)
- •Insulin glulisine (U-100), or
- •Regular insulin (U-100)
- •Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening
- •dipeptidyl peptidase IV inhibitors
- •sodium-glucose co-transporter-2 inhibitors
- •biguanides (for example, metformin), or
- •glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study
- •Have a body mass index ≤45 kilogram/square meter (kg/m²)
排除标准
- •Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D (for example, monogenic diabetes, diseases of the exocrine pancreas, drug-induced or chemical-induced diabetes).
- •Are currently receiving any of the following insulin therapies anytime in the past 90 days:
- •insulin mixtures
- •insulin human, inhalation powder, or
- •continuous subcutaneous insulin infusion therapy, or
- •regular insulin U-500
- •Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
- •Have had any episodes of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening
- •Have hypoglycemia unawareness in the opinion of the investigator
- •Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for example, initiation, stopping, or changing device) during the study.
- •Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
- •Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, or sleeve gastrectomy within 1 year prior to screening
研究组 & 干预措施
500 U/mL - Insulin Efsitora
Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin lispro given SC with meals as needed.
干预措施: Insulin Efsitora Alfa (Drug)
500 U/mL - Insulin Efsitora
Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin lispro given SC with meals as needed.
干预措施: Insulin Lispro (U100) (Drug)
100 U/mL - Insulin Glargine
Participants received 100 U/mL insulin glargine administered SC once daily (QD) along with 100 U/mL insulin lispro given SC with meals as needed.
干预措施: Insulin Lispro (U100) (Drug)
100 U/mL - Insulin Glargine
Participants received 100 U/mL insulin glargine administered SC once daily (QD) along with 100 U/mL insulin lispro given SC with meals as needed.
干预措施: Insulin Glargine (U100) (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]
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.
次要结局
- Change From Baseline in HbA1c [Superiority](Baseline, Week 26)
- Percentage of Participants Achieving HbA1c <7% Without Nocturnal Hypoglycemia(Week 26)
- Nocturnal Hypoglycemia Event Rate(Baseline Up To Week 26)
- Change From Baseline in Fasting Glucose(Baseline, Week 26)
- Percentage of Time in Glucose Range(Week 22 to Week 26)
- Percentage of Time in Hypoglycemia Range(Week 22 to Week 26)
- Percentage of Time in Hyperglycemia Range(Week 22 to Week 26)
- Glucose Variability Between Weeks 22 to 26(Week 22 to Week 26)
- Basal Insulin Dose at Week 26(Week 26)
- Bolus Insulin Dose at Week 26(Week 26)
- Total Insulin Dose at Week 26(Week 26)
- Basal Insulin Dose to Total Insulin Dose Ratio at Week 26(Week 26)
- Hypoglycemia Event Rate(Baseline up to Week 26)
- Change From Baseline in Body Weight(Baseline, Week 26)
- Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ)(Week 26)