Diabetes with Chronic Heart Failure
Conditions
Interventions
Imeglimin (Twimeg tablets 500 mg 2tablets orally 2 times a day,in the morning and evening) will be started and continued until 52 weeks of administration. If the eGFR is more than 15 mL/min/1.73 m2 an
Sponsors
Makino Hisashi
Sakata Yasuhiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetes patients aged 20 years or older 2) Patients with a HbA1c level of 6.5% or higher and less than 9.0% within the last 4 weeks before the date of consent 3) Patients with stage C heart failure 4) Patients who have been taking SGLT2 inhibitors, including combination tablets, for 12 weeks or more and have not changed their dosage or administration since 12 weeks before the date of consent 5) Patients who have provided written consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed or suspected to have mitochondrial disease 2) Patients currently hospitalized for the treatment of diabetes 3) Patients for whom Imeglimin is contraindicated i) Patients with a history of hypersensitivity to the components of Imeglimin ii) Patients with severe ketosis, diabetic coma or pre-diabetic coma, or type 1 diabetes iii) Patients with severe infection, before or after surgery, or severe trauma 4) Patients who have been administered Imeglimin within the past year 5) Patients with a history of side effects in 99mTc-MIBI/123I-BMIPP testing 6) Patients with an estimated glomerular filtration rate (eGFR) of <10mL/min/1.73m2 within the past 4 weeks prior to obtaining consent 7) Patients currently receiving thiazolidinedione 8) Patients who have received additional GLP-1 receptor agonists or changed their dosage within the past year prior to obtaining consent 9) Patients who have changed the dosage of their antidiabetic medication (excluding GLP-1 receptor agonists) within 12 weeks prior to obtaining consent. 10) Patients who have received additional medication or changed the dosage of their heart failure medication within 12 weeks prior to obtaining consent. 11) Patients who have been hospitalized for treatment of heart failure or other heart disease within 12 weeks prior to obtaining consent (including patients who are scheduled to be hospitalized during the study period). 12) Patients with severe valvular heart disease within 12 weeks prior to obtaining consent. 13) Patients who have changed the dosage of their dyslipidemia medication within 12 weeks prior to obtaining consent. 14) Patients who are pregnant, breastfeeding, or wish to become pregnant during the study period. 15) Patients who are otherwise deemed inappropriate as study subjects by the principal investigator (subinvestigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in 99mTc-MIBI washout rate at 52 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Myocardial fatty acid metabolism Change from baseline in 123I-BMIPP washout rate at 52 weeks of administration 2) Proteome analysis 1.Changes from baseline at 24 and 52 weeks of administration in the incidence of cardiovascular events (all-cause mortality, hospitalization for heart failure, myocardial infarction, and stroke) predicted to occur over a 4-year period, calculated based on the results of analysis of proteins listed in Appendix 1 of the study protocol (Names of proteins and their abbreviations predicting the risk of major cardiovascular events) 2. Change from baseline in expression levels at 24 and 52 weeks of administration of proteins related to the following pathologies: renal failure, dementia 3. Change from baseline in expression levels at 24 and 52 weeks of administration of the following biomarkers myocardial injury myocardial specific troponin concentration I and T renal and glomerular injury Collagen IV, cystatin C Pancreatic beta-cell injury Insulin Inflammation TNF-alpha, IL-6, CRP 4. Comprehensive expression changes from baseline at 24 and 52 weeks for proteins other than those mentioned above 3) Lipidome analysis Changes from baseline at 24 and 52 weeks after administration of the following long-chain fatty acids Long-chain fatty acids: Lauric acid, myristic acid, palmitic acid, stearic acid, arachidic acid, behenic acid, lignoceric acid, palmitoleic acid, oleic acid, linoleic acid, gamma-linoleic acid, arachidonic acid, alpha-linolenic acid, eicosapentaenoic acid, docosahexaenoic acid 4) Cardiac function At 12 weeks after administration of the following evaluation items, Changes from baseline at 24 and 52 weeks Cardiac function evaluation items: Left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular end-diastolic volume index, left ventricular end-systolic volume index, left ventricular ejection fraction, left ventricular mass index, left atrial diameter, left atrial volume index, right ventric | — |
Contacts
Public ContactYasuhiko Sakata
National Cerebral and Cardiovascular Center
Outcome results
None listed