Type 2 diabetes with acute myocardial infarction
Conditions
Interventions
Empagliflozin 10 mg is administered orally before or after breakfast once daily for 24 weeks, and initiation period of administration is 2 to 12 weeks after the onset of acute myocardial infarction.
P
Sponsors
Nippon Medical School Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years or older at consent 2) Patients who meet the following items - Subjects appropriately diagnosed as T2DM by the latest Japanese guideline - Drug-naive subjects or taking single anti-diabetic agent - T2DM patients who need to start, or are possibly changing or adding an anti-diabetic agent 3) Patients with acute myocardial infarction who can receive outpatient visits after discharge
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes mellitus 2) Persistent atrial fibrillation 3) Insulin, glucagon-like peptide-1 analogue, or other SGLT2 inhibitors user 4) High dose of sulfonylurea (glimepiride > 2 mg, glibenclamide > 1.25 mg, gliclazide > 40 mg) 5) HbA1c >= 10% 6) History of diabetic ketoacidosis or diabetic coma within 3 months prior to the randomization 7) Renal dysfunction (eGFR < 45 mL/min/1.73m2) 8) Heart failure graded at NYHA functional class IV 9) Pregnancy or possible pregnancy and breast feeding 10) Lack of informed consent 11) Patients judged by the investigator to be ineligible for inclusion in this study 12) Contraindicated for administration of empagliflozin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the change from baseline of HRV at 24 weeks treatment between two groups 1) Time domain analysis [mean RR interval for 24 h (mean NN), standard deviation of normal RR intervals (SDNN), standard deviation of all 5-min mean normal RR intervals (SDANN), square root of the mean of the sum of the squares of differences between adjacent RR intervals (r-MSSD), and percentage of adjacent RR intervals differing > 50 ms (pNN50)] 2) Frequency domain analysis: [Total power (TP, 0-0.4 Hz), high-frequency (HF, 0.15-0.4 Hz), low-frequency (LF, 0.04-0.15 Hz), and sympathovagal balance (LF/HF ratio)] | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the change from baseline in the clinical tests listed in the followings at 24 weeks treatment between two groups 1) TWA, LP, and HRT assessed by Ambulatory ECG (SCM-8000) 2) Cardiac sympathetic activity assessed by 123I-MIBG Scintigraphy 3) Blood pressure, body weight, BMI, HbA1c (NGSP), fasting plasma glucose, Serum lipids [TC, LDL-C (direct method), HDL-C, TG, and non-HDL-C], AST, ALT, gamma-GTP, UA, serum creatinine, eGFR (adjusted value), NT-pro BNP, serum ketone body (venous blood), and blood count (RBC, WBC, hemoglobin, hematocrit, and platelet), cystatin C, hs-CRP 4) Body fluid volume assessed by InBody | — |
Countries
Japan
Contacts
Public ContactYoshiaki Kubota
Nippon Medical School Hospital Department of Cardiovascular Medicine
Outcome results
None listed