A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly Versus Insulin Lispro (U100) Three Times Daily in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,428
- 试验地点
- 133
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.
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 mellitus (T2DM)
- •Have HbA1c between ≥7.5% and ≤11%
- •Have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors
- •Be of stable weight (± 5%) for at least 90 days
- •Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 kg/m² at screening
- •Exclusion Criteria
- •Have type 1 diabetes mellitus
- •Have had chronic or acute pancreatitis any time prior to study entry
- •Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment
- •Have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility
- •Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
- •Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
- •Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
- •Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)]
排除标准
- 未提供
研究组 & 干预措施
5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
干预措施: Tirzepatide (Drug)
10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
干预措施: Tirzepatide (Drug)
15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
干预措施: Tirzepatide (Drug)
Insulin Lispro
Insulin lispro 100 units per milliliter (U100) administered SC three times a day.
干预措施: Insulin Lispro (U100) (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
时间窗: Baseline, Week 52
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
次要结局
- Percentage of Participants Who Achieved Weight Loss ≥5%(Week 52)
- Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score(Baseline, Week 52)
- Change From Baseline in HbA1c(Baseline, Week 52)
- Percentage of Participants With HbA1c Target Values <7.0%(Week 52)
- Change From Baseline in Body Weight(Baseline, Week 52)
- Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week 52)
- Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score(Baseline, Week 52)
- Change From Baseline in Fasting Serum Glucose(Baseline, Week 52)
- Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia(Week 52)