NCT07313813已完成1 期
A Study to Evaluate the Effect of Fasting Duration and Temporary Withholding of Dulaglutide on Retained Gastric Contents Using Gastric Ultrasound in Participants With Type 2 Diabetes Mellitus
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal
研究概览
简要总结
The purpose of this study is to evaluate how fasting and stopping the use of Dulaglutide (LY2189265) affect the amount of food and drink that stays in your stomach after a meal.
Ultrasound devices will be used to check the stomach content after a test meal.
The study can last approximately 28 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with Type 2 Diabetes Mellitus (T2DM) as determined by medical history and have:
- •a diagnosis of T2DM for at least 6 months
- •T2DM controlled with diet and exercise alone or are on a stable dose of metformin, with or without 1 additional oral antihyperglycemic medication, a dipeptidyl peptidase-4 (DPP-4) inhibitor or sodium glucose transporter-2 inhibitor (SGLT-2i), for at least 1 month, and
- •a hemoglobin A1c value at screening of greater than or equal to 6.5% and less than or equal to 10.0%
排除标准
- •Have a known clinically significant gastric emptying abnormality (for example, gastroparesis or gastric outlet obstruction), have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, Lap-Band®), or have had endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal bypass sleeve)
- •Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data
- •Participants who have clinical laboratory test results, blood pressure, and pulse rate that are outside the normal reference range for the population
- •Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency or Prader-Willi Syndrome)
研究组 & 干预措施
Dulaglutide (LY2189265)-Liquid-Meal
Experimental
Administered SC
干预措施: Dulaglutide (Drug)
Dulaglutide (LY2189265)-Solid-Meal
Experimental
Administered subcutaneously (SC)
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal
时间窗: Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)
Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal
次要结局
- Percentage of Fasting Participants with Lack of Gastric Content Retention After Dulaglutide (LY2189265) Post-Liquid Test Meal(Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal))
- Percentage of Fasting Participants with Lack of Gastric Content Volume Post-Liquid Test Meal After Dulaglutide (LY2189265)(Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal))
- Percentage of Fasting Participants with Lack of Gastric Content Volume Post-Solid Test Meal After Dulaglutide (LY2189265)(Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal))
- Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265)(Baseline, through 8 days after discontinuation of dulaglutide at 6, 8, 12, 18 and 24 hours)
- Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Solid Test Meal After Dulaglutide (LY2189265)(Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal))
- Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Liquid Test Meal After Dulaglutide (LY2189265)(Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal))
- Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265)(Baseline, through 8 days after discontinuation of dulaglutide at 6, 8, 12, 18 and 24 hours)
研究者
研究点 (1)
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