NCT05275400已完成3 期
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 986
- 试验地点
- 127
- 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 see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 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 been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
- •Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
- •Have HbA1c value of 6.5% - 10% inclusive, at screening
- •Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
- •Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:
- •once daily U100 or U200 of insulin degludec
- •once daily U100 or U300 of insulin glargine
- •once or twice daily U100 of insulin detemir, or
- •once or twice daily human insulin NPH
- •acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
- •dipeptidyl peptidase (DPP-4) IV inhibitors
- •SGLT2 inhibitors
- •metformin
- •alphaglucosidase inhibitors or,
- •Glucagon-Like Peptide-1 (GLP-1) receptor agonists
- •Participants must be willing to stay on stable dose throughout the study
排除标准
- •Have Type 1 diabetes mellitus
- •Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
- •Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)
- •Have active or untreated malignancy
- •Are pregnant
- •Have a significant weight gain or loss the past 3 months
- •Have received anytime in the past 6 months, any of the following insulin therapies:
- •prandial insulin
- •insulin mixtures
- •inhaled insulin
- •U-500 insulin, or
- •continuous subcutaneous insulin infusion therapy
- •Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:
- •acute myocardial infarctions
- •cerebrovascular accident (stroke), or
- •coronary bypass surgery
- •Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening
研究组 & 干预措施
500 U/mL - Insulin Efsitora
Experimental
Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).
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).
干预措施: Insulin Degludec (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. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach.
次要结局
- Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority](Baseline, Week 26)
- Nocturnal Hypoglycemia Event Rate(Baseline up to Week 78)
- Percentage of Time in Glucose Range Between 70 and 180 mg/dL (3.9 and 10.0 mmol/L)(Week 22 to Week 26)
- Change From Baseline in Fasting Glucose(Baseline, Week 26)
- Weekly Insulin Dose at Week 26(Week 26)
- Hypoglycemia Event Rate(Baseline up to Week 78)
- Change From Baseline in Body Weight(Baseline, Week 78)
- Percentage of Time in Hypoglycemia Range(Week 22 to Week 26)
- Percentage of Time in Hyperglycemia Range(Week 22 to Week 26)
- Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)(Baseline, Week 26, Week 52, Week 78)
- Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26(Week 26)
- Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52(Week 52)
- Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78(Week 78)
研究者
研究点 (127)
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