Effect of Imeglimin on Blood Glucose Variability
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCTs051220061
- Lead Sponsor
- Hirota Yushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1) Patients who have been diagnosed with type 2 diabetes at the time of obtaining consent
2) Patients who are between 20 and 75 years of age at the time of consent.
3) Patients whose HbA1c level measured at the time of eligibility test is between 6.5% and 9.5%.
4) Patients with a body mass index (BMI) of 18.5 k g/m2 or higher at the time of the eligibility test.
5) Patients who have given written consent to participate in this clinical study.
1) Patients using insulin, glucagon-like peptide-1 receptor agonist (GLP-1 RA), or two or more oral hypoglycemic agents (including combination products containing two oral hypoglycemic agents)
2) Patients with contraindications listed in the package inserts for imeglimine, metformin, and the FreeStyle Libre Pro sensor and reader (contraindications for the FreeStyle Libre Pro sensor and reader: patients with pacemakers or other implantable medical devices)
3) Patients with proliferative diabetic retinopathy (except for patients with old proliferative diabetic retinopathy who do not require treatment)
4) Patients with severe diabetic neuropathy (patients whose symptoms are so severe that they seriously interfere with daily life and require assistance)
5) Patients with a New York Heart Association (NYHA) cardiac function classification of degree III or IV at evaluation within 1 year.
6) Patients who are heavy drinkers (daily consumption of 3 or more drinks is recommended)
7) Patients with a history of lactic acidosis
8) Patients with a history of severe ketosis, diabetic coma or precoma
9) Patients who have undergone surgery with general anesthesia within one month
10) Patients with severe infection or serious trauma
11) Patients with malignant tumors under treatment or within 5 years of completion of treatment
12) Patients with severe hepatic dysfunction at the time of eligibility testing (non-compensated cirrhosis or AST/ALT greater than 4 times the upper limit of normal)
13) Patients with renal dysfunction at the time of eligibility testing (estimated glomerular filtration rate [eGFR] less than 45 mL/min/1.73m2)
14) Patients who have undergone gastrectomy (not including endoscopic mucosal resection)
15) Pregnant women, lactating women, and patients who may be or plan to become pregnant
16) Patients participating in clinical research involving other interventions.
17) Patients who are judged by the principal investigator or sub-investigator to be inappropriate for t his clinical research.
Exclusion criteria 12) and 13) shall be at the time of eligibility testing; otherwise, at the time of obtaining consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method