A Phase 4 Study to Evaluate Glucodynamic Effects of Dulaglutide in Japanese Patients With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-jRCT1080223698
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- Not specified
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method