A Phase 4 Study to Evaluate Glucodynamic Effects of Dulaglutide in Japanese Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h])
研究概览
简要总结
The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes (based on the World Health Organization [WHO] diagnostic criteria) for at least 1 year.
- •Have diet and exercise therapy only (no oral antihyperglycemic medication for at least 3 months prior to screening).
- •Have a fasting blood glucose value of ≥120 and ≤200 milligrams per deciliter (mg/dL) at screening.
- •Have a screening body weight of ≥50 and ≤80 kilograms.
排除标准
- •Have known allergies to dulaglutide, or other glucagon-like peptide-1 (GLP-1) receptor agonists.
- •Have had a clinically significant cardiovascular disease.
- •Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery.
- •Have acute or chronic hepatitis, signs and symptoms of any other liver disease.
- •Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis.
- •Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 meter squared.
- •In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
研究组 & 干预措施
Dulaglutide, Placebo
Dulaglutide 0.75 mg administered subcutaneously (SC) once weekly for 4 weeks in period 1 followed by placebo administered SC once weekly for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2.
干预措施: Dulaglutide (Drug)
Dulaglutide, Placebo
Dulaglutide 0.75 mg administered subcutaneously (SC) once weekly for 4 weeks in period 1 followed by placebo administered SC once weekly for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2.
干预措施: Placebo (Drug)
Placebo, Dulaglutide
Placebo administered SC once weekly for 4 weeks in Period 1 followed by Dulaglutide 0.75 mg administered SC for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2.
干预措施: Dulaglutide (Drug)
Placebo, Dulaglutide
Placebo administered SC once weekly for 4 weeks in Period 1 followed by Dulaglutide 0.75 mg administered SC for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h])
时间窗: Baseline, 4 Weeks
Least square (LS) means of glucose AUC 0-4h change from baseline was calculated using mixed-effects linear model. The model will include treatment, sequence, period, week, and treatment-by-week as fixed effects, baseline as a covariate, and participant as random effect.
次要结局
- Change From Baseline in Fasting Blood Glucose(Baseline, 4 Weeks)
- Change From Baseline in Postprandial Blood Glucose(Baseline, 4 Weeks)
- Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])(Baseline, 4 Weeks)
- Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])(Baseline, 4 Weeks)
- Number of Participants Who Develop Hypoglycemic Events(Baseline through 4 weeks)
- Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])(Baseline, 4 Weeks)
- Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])(Baseline, 4 Weeks)