A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Tirzepatide Monotherapy Compared With Placebo in Chinese Participants With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 28
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy 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
- 否
入选标准
- •Have Type 2 Diabetes
- •Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol) despite diet and exercise treatment
- •Are of stable weight 5%) during the 90 days preceding screening and agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
- •Have Body Mass Index (BMI) ≥23.0 kilogram per square meter (kg/m²)
排除标准
- •Have Type 1 Diabetes
- •Have a history of chronic or acute pancreatitis any time prior to study entry
- •Are currently receiving treatment for diabetic retinopathy and/or macular edema
- •Have a history of ketoacidosis or hyperosmolar state/coma
- •Have a history of New York Heart Association Functional Classification IV congestive heart failure (CHF)
- •Have acute or chronic hepatitis including a history of autoimmune hepatitis
- •Use of insulin 1-year preceding screening and between screening and baseline; use of any antihyperglycemic medication 90 days preceding screening and between screening and baseline.
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 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
Change From Baseline in Hemoglobin A1c (HbA1c)
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 ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.
次要结局
- Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])(Week 40)
- Change From Baseline in Fasting Serum Glucose(Baseline, Week 40)
- Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)(Week 40)
- Change From Baseline in Body Weight(Baseline, Week 40)
- Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)(Week 40)
- Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥5%(Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥10%(Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥15%(Week 40)