Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide Versus Placebo in Patients With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 47
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) (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 placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.
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
- Double (Participant, Investigator)
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) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.
- •Have HbA1c between ≥7.0% and ≤10.5%.
- •Have a stable weight (± 5%) for at least 3 months before screening.
- •Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.
排除标准
- •Have type 1 diabetes mellitus.
- •Have had chronic or acute pancreatitis any time prior to study entry.
- •Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
- •Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
- •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)]
- •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
- •Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
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)
Placebo
Placebo administered SC once a week.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
时间窗: Baseline, Week 40
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 Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
次要结局
- Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week 40)
- Percentage of Participants Achieving an HbA1c Target Value of <5.7%(Week 40)
- Change From Baseline in HbA1c (5 mg)(Baseline, Week 40)
- Change From Baseline in Body Weight(Baseline, Week 40)
- Change From Baseline in Fasting Serum Glucose(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss ≥5%(Week 40)
- Percentage Change From Baseline in Daily Mean Insulin Glargine Dose(Baseline, Week 40)
- Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia(Baseline through Safety Follow-Up (Up to Week 44))
- Percentage of Participants Achieving an HbA1c Target Value of <7%(Week 40)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide(Week 7, 15, 23 and 39 post dose)