A Randomized, Phase 3, Double Blind Trial Comparing the Effect of the Addition of Tirzepatide Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Participants With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 25
- 主要终点
- Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])
研究概览
简要总结
The main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes.
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
- 是
入选标准
- •Have type 2 diabetes mellitus (T2DM)
- •Have HbA1c ≥7.0% (53 mmol/mol) to ≤11% (97 mmol/mol)
- •Have been treated with insulin glargine (U100) once daily alone, or in combination with metformin with or without SGLT-2i ≥90 days
- •Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²)
排除标准
- •Have type 1 diabetes mellitus (T1DM)
- •Have a history of chronic or acute pancreatitis
- •Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment
- •Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
- •Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
- •Have a history of diabetic ketoacidosis or hyperosmolar state/coma within the 6 months
- •Have acute myocardial infarction, or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (CHF) in the past 2 months
- •Have a serum calcitonin level of ≥35 ng/L, as determined by central laboratory
- •Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >3.0 times the upper limit of normal (ULN), as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial only if their ALT level is ≤3.0 times ULN.
研究组 & 干预措施
5 Milligram (mg) Tirzepatide
Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose injection pen (SDP) once weekly (QW) for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
干预措施: Tirzepatide (Drug)
10 mg Tirzepatide
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
干预措施: Tirzepatide (Drug)
15 mg Tirzepatide
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
干预措施: Tirzepatide (Drug)
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [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 calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
次要结局
- Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)(Baseline, Week 40)
- Mean Change From Baseline in Body Weight(Baseline, Week 40)
- Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)(Week 40)
- Mean Change From Baseline in Fasting Serum Glucose(Baseline, Week 40)
- Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg](Week 40)
- Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg](Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥5%(Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥15%(Week 40)
- Percent Change From Baseline in Daily Mean Insulin Glargine Dose(Baseline, Week 40)
- Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥10%(Week 40)
- Percentage of Participants With HbA1c <7.0%, Without Weight Gain (<0.1 Kilogram [kg]) and Without Hypoglycemia, (Blood Glucose <3.0 mmol/L <54 Milligram/Deciliter [mg/dL])(Week 40)
- Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.0 mmol/L [54 mg/dL])(Week 40)
- Percentage of Participants With HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)(Week 40)
- Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)(Week 40)