The Effect of Tirzepatide on α and β Cell Function and Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Change From Baseline in Total Clamp Disposition Index (cDI)
研究概览
简要总结
This is a study for participants with type 2 diabetes mellitus. The main purpose of this study is to learn more about how tirzepatide, semaglutide and placebo affect the body's ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks, including a 28-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have T2DM for at least 6 months
- •Treated with diet and exercise and stable dose(s) of metformin, with or without 1 additional stable dose of oral antihyperglycemia medication other than metformin, 3 months prior to study entry
- •Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia medications other than metformin
- •Have a body mass index (BMI) between 25 and 45 kilograms per square meter (kg/m² ) inclusive, at screening; are of stable weight (±5%) >3 months prior to screening
排除标准
- •Have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (<1.5 years) ophthalmologic examination
- •Impaired renal estimated glomerular filtration rate (eGFR) <45 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
- •Have a history or current cardiovascular, respiratory, hepatic, renal, GI,endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
研究组 & 干预措施
Tirzepatide 15 mg
Participants received 15 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 28 weeks.
干预措施: Tirzepatide (Drug)
Semaglutide 1 mg
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
干预措施: Semaglutide (Drug)
Placebo
Participants received Placebo administered SC once weekly for 28 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Clamp Disposition Index (cDI)
时间窗: Baseline, Week 28
cDI is defined as the product of the M-value derived from the hyperinsulinemic euglycemic clamp over the last 30 minutes and total insulin secretion (ISR AUC0-120min) derived from the insulin secretion rate based on C-peptide using the using the deconvolution technique divided by the total glucose AUC0-120min from the hyperglycemic clamp portion of the study. Least squares (LS) mean was determined by analysis of covariance (ANCOVA) model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment (Type III sum of squares).
次要结局
- Change From Baseline in Postmeal Glucose(Baseline, Week 28)
- Change From Baseline in Food Intake During Ad Libitum Meal(Baseline, Week 28)
- Change From Baseline in Fasting Glucose(Baseline, Week 28)
- Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 28)
- Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value(Baseline, Week 28)
- Change From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min)(Baseline and Week 28)
- Change From Baseline in Glucagon Concentration at Fasting(Baseline and Week 28)
- Change From Baseline in Glucagon Concentration at Postmeal(Baseline and Week 28)