Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Point of Care Ultrasound (POCUS)
Brief summary
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.
Interventions
DRUGDulaglutide
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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%
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Retention After Dulaglutide (LY2189265) Post-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-Liquid Test Meal After Dulaglutide (LY2189265) |
| 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 Fasting Participants with Lack of Gastric Content Volume Post-Solid Test Meal After Dulaglutide (LY2189265) |
| 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 Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265) |
| 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-Solid Test Meal After Dulaglutide (LY2189265) |
| 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-Liquid Test Meal After Dulaglutide (LY2189265) |
| 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 | Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265) |
Countries
Singapore
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed