NCT05362058已完成3 期
A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 928
- 试验地点
- 113
- 主要终点
- Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis]
研究概览
简要总结
The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 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 diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria
- •Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening
- •Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study
- •These antihyperglycemic medications are accepted in the study
- •dipeptidyl peptidase-4 (DPP-4) inhibitors
- •sodium-glucose cotransporter 2 (SGLT2) inhibitors
- •biguanides, such as metformin
- •alpha-glucosidase inhibitors
- •glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
- •Sulfonylureas, or
- •Thiazolidinediones.
- •Are insulin naïve.
- •Exceptions:
- •short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes
- •Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).
排除标准
- •Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a 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 greater than (>) 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 a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.
- •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, greater than or equal to (≥) 5%.
研究组 & 干预措施
500 U/mL - Insulin Efsitora Alfa
Experimental
- Participants received 500 units per milliliter (U/mL) of insulin efsitora alfa administered subcutaneously (SC) once weekly (QW) over a 52-week treatment period, followed by a 5-week safety follow-up period.
- Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.
干预措施: Insulin Efsitora Alfa (Drug)
100 U/mL - Insulin Degludec
Active Comparator
- Participants received 100 U/mL insulin degludec administered SC once daily (QD) over a 52-week treatment period, followed by a 5-week safety follow-up period.
- Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.
干预措施: Insulin Degludec (Drug)
结局指标
主要结局
Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis]
时间窗: Baseline, Week 52
* 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 using Analysis of Covariance (ANCOVA) model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.
次要结局
- Change From Baseline in HbA1c at Week 52 in Participants Using GLP-1 Receptor Agonists [Noninferiority Analysis](Baseline, Week 52)
- Change From Baseline in HbA1c at Week 52 in Participants Not Using GLP-1 Receptor Agonists [Noninferiority Analysis](Baseline, Week 52)
- Change From Baseline in HbA1c at Week 52 [Superiority Analysis](Baseline, Week 52)
- Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 48 to Week 52(Week 48 to Week 52)
- Change From Baseline in 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] - Week 22 to Week 26(Week 22 to Week 26)
- Change From Baseline in Fasting Blood Glucose (FBG)(Baseline, Week 26, Week 52)
- Glucose Variability(Week 22 to Week 26 and Week 48 to Week 52)
- Basal Insulin Dose(Week 26 and Week 52)
- Hypoglycemia Event Rate(Baseline up to Week 52)
- Nocturnal Hypoglycemia Event Rate(Baseline up to Week 52)
- Change From Baseline in Body Weight(Baseline, Week 26, Week 52)
- Percentage of Time in Hypoglycemia Range With Blood Glucose <70 mg/dL (3.9 mmol/L)(Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52)
- Percentage of Time in Hypoglycemia Range With Blood Glucose <54 mg/dL (3.0 mmol/L)(Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52)
- Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L)(Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52)
- Change From Baseline in Treatment-Related Impact Measures for Diabetes (TRIM-D) -Total Score at Week 26 and Week 52(Baseline, Week 26, Week 52)
- Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores at Week 26 and Week 52(Baseline, Week 26, Week 52)
- Change From Baseline in EuroQuality of Life (EuroQol) - 5 Dimensions-5 Levels (EQ-5D-5L) Health State Index and EQ Visual Analog Scale (VAS) Scores at Week 26 and Week 52(Baseline, Week 26, Week 52)
研究者
研究点 (113)
Loading locations...
相似试验
已完成
3 期
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection TherapyDiabetesType 1 DiabetesNCT05463744Eli Lilly and Company692
已完成
3 期
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)T2DType 2 DiabetesNCT05662332Eli Lilly and Company795
已完成
3 期
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal InsulinType 2 DiabetesNCT05275400Eli Lilly and Company986
已完成
3 期
A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily InjectionsType 2 Diabetes Treated With InsulinType 2 DiabetesNCT05462756Eli Lilly and Company730
已完成
1 期
A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin PumpDiabetes Mellitus, Type 1NCT05262595Novo Nordisk A/S19