Elucidation of Mechanisms Underlying Glucose-lowering Effect of Dulaglutide Using C13-acetate Breath Test and Its Anti-arteriosclerotic Effect Using Endothelial Function Test in Japanese Working T2DM Patients
- Conditions
- T2DM
- Registration Number
- JPRN-UMIN000026679
- Lead Sponsor
- Osaka Rosai Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Not provided
(1)Patients with history of chronic pancreatitis, inflammatory bowel disease, pancreatectomy or gastrectomy (2)Patients with history of metabolic acidosis including diabetic ketoacidosis during the previous 1 year (3)Patients with history of stroke or myocardial infarction requiring hospitalization during the previous 6 months (4)Patients with severe or uncontrolled congestive heart failure (5)Patients with drug or alcohol abuse during the previous 6 months (6)Patients having hepatic dysfunction with AST or ALT greater than 5 times the upper limit of the normal laboratory range at the time of screening (7)Patients having uncontrolled hypertension with a resting systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mmHg at the time of screening (8)Patients with end-stage renal dysfunction and/or dialysis (9)Patients having clinically relevant history of gastrointestinal disease with prolonged nausea and vomiting during the previous 6 months (10)Pregnant or possibly pregnant women (11)Patients judged as inadequate to participate in the present study by Investingator or sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tlag (Tmax-cal) and T1/2 on C13-acetate breath test carried out after insulin/dulaglutide treatment
- Secondary Outcome Measures
Name Time Method