Investigation of the mechanism of action of imeglimin using the glucose clamp test
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCTs051220028
- Lead Sponsor
- Sakaguchi Kazuhiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
(1)Patients between 20 and 75 years old
(2)Patients diagnosed with type 2 diabetes mellitus
(3)BMI of the patients more than 18.5 kg/m2
(4)Patients who have been taking only diet and ex ercise therapy or only dipeptidyl peptidase 4 (DPP 4) inhibitors without changing the dosage and ad ministration for the treatment of diabetes for at least 8 weeks prior to obtaining consent
(5)Patients whose HbA1c is less than 9.5 % at the time of eligibility test
(6)Patients who have given their free and written consent to participate in this clinical research
(1)Patients using insulin, GLP-1RA, or oral hypoglycemic agents other than DPP4 inhibitors
(2)Patients with severe hepatic dysfunction (AST/ALT greater than 4 times the upper limit of normal)
(3)Patients with renal dysfunction (eGFR less than 45 mL/min/1.73m2)
(4)Patients who have undergone gastrectomy (not including endoscopic mucosal resection)
(5)Patients with proliferative diabetic retinopathy ( except for patients with obsolete proliferative diabetic retinopathy that does not require treatment)
(6)Patients with severe diabetic neuropathy (patients whose symptoms are so severe that they seriously interfere with daily life and require assistance)
(7)Patients with a cardiac function classification of grade 3 or 4 according to NYHA at an evaluation within the last year
(8)Patients who drink excessively and habitually
(9)Patients with a history of lactic acidosis
(10)Patients with a history of severe ketosis, diabetic coma, or precoma
(11)Patients who have undergone major surgery within one month
(12)Patients with severe infection or serious trauma
(13)Patients with malignant tumors under treatment or within 5 years of completion of treatment
(14)Pregnant women, lactating women, and patients who may be or are planning to become pregnant
(15)Patients who have used antibiotics or antiparasitic drugs within one month prior to eligibility confirmation
(16)Patients who have taken PPI (proton pump inhibitor), steroids, or immunosuppressive drugs within one month prior to eligibility confirmation
(17)Patients with lower gastrointestinal diseases ( Crohn's disease, ulcerative colitis, short bowel syndrome, celiac disease, etc.)
(18)Patients who are participating in clinical research involving other interventions(However, participation in the Study to evaluate intestinal FDG accumulation on 18F-FDG-PET/MRI in patients taking imegurimine or metformin is acceptable)
(19)Patients who are judged by the principal investigator or sub-investigator to be inappropriate for this clinical research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method