Type 2 Diabetes Mellitus
Conditions
Interventions
Group A: Administer empagliflozin
Patients in the empagliflozin group take empagliflozin 10 mg once a day orally before or after breakfast for 12 weeks.
Group B: Administer sitagliptin
Patients b
Sponsors
the Japan Society for Patient Reported Outcome (PRO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study: 1. At the time of giving consent, T2DM patients whose HbA1c (NGS) is out of the range set by the Treatment Guide for Diabetes 2016-2017, which is 6.0% or higher and below 10.0% even though patients have treated with 1) a dietary and exercise regimen, or 2) monotherapy of any alpha-glucosidase inhibitor, sulphonylurea*, or glinide-based medicine in addition to a dietary and exercise regimen, or 3) a combination therapy of any alpha-glucosidase inhibitor and sulphonylurea* medicine, or any alpha-glucosidase inhibitor and glinide-based medicine in addition to a dietary and exercise regimen 2. Male and female patients who are at age of 20 years or older and younger than 75 years when giving their consent 3. Patients with BMI 22 kg/m2 or greater 4. Patients who can give their consent in a written form *Up to glimepiride 2 mg, glibenclamide 1.25 mg, and gliclazide 40 mg are considered as sulphonylurea treatment regimen
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study: 1. Type 1 diabetes mellitus or secondary diabetes 2. Patients with BMI below 22kg/m2 3. Moderate to severe renal function impairment or at the terminal stage of renal failure (eGFR below 45mL/min/1.73m2) 4. Patients who had stroke, cerebral infarction within 12 weeks before giving their consent 5. Patients with myocardial infarction or angina pectoris in the past, or with atrial fibrillation currently 6. Patient with LVEF below 30% 7. Patients with infectious disease 8. Patients with malignancy (However, those who have completed treatment and/or show no redevelopment of malignancy, as well as manifest some degree of remission can be considered to be participants of this study) 9. Patients with connective tissue disease (However, those T2DM patients who have treated with prednisolone 5mg or less and show stable conditions can be considered to be participants of this study) 10. Patients with hepatocirrhosis 11. Patients with viral or autoimmune, or drug-induced hepatitis 12. Patients who are alcoholic or excessive drinkers 13. Patients are currently pregnant, possibly pregnant, breast-feeding, or planning to be pregnant during the study 14. Patients have a medical history of hypersensitivity to the study drugs 15. If the study drugs are contradicted to use 16. Patients with Hb below 12g/dl 17. Patients with other conditions that the investigator/researcher thinks inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changed amount and percent change from baseline of the following value are evaluated: * Amount of pericardial fat | — |
Secondary
| Measure | Time frame |
|---|---|
| The changed amount and percent change from baseline of each value below are evaluated: 1. Myocardial intracellular fat amount 2. Cardiac function 3. Amount of fat accumulation in tissue (liver intracellular lipid content, intramyocellular and extramyocellular lipid contents) 4. Insulin sensitivity (in myocardium, liver, muscle, adipose tissue) 5. Myocardial fatty acid metabolism index (123I-BMIPP uptake (early/first-half image), 123I-BMIPP uptake (latter/second-half image), washout rate) 6. % suppression of EGP (suppression of hepatic glucose production rate) 7. Glucose infusion rate (GIR) 8. Glucose disappearance rate (Rd) 9. Insulin secretion index (C-peptide, plasma insulin, HOMA-beta) 10. Insulin resistance index (HOMA-IR) 11. Other insulin sensitivity index (D2Glucose, glucose level, FFA) 12. Blood glucagon 13. Energy metabolism index (calorimetric examination: amount of energy consumption, oxygen consumption and carbon dioxide emission) 14. Cardiac metabolism marker (renin activity, aldosterone, aldosterone/renin activity ratio, BNP, H-FABP) 15. Oxidation stress marker (urinary 8OHdG) 16. Inflammatory marker (hsCRP) 17. Adipose tissue hormone index (high-molecular weight adiponectin, leptin) 18. Other blood test item (quantitative albumin, HbA1c, blood glucose, TG, T-Cho, HDL, LDL, complete blood count, Na, K, Cl, uric acid, Amy, serum creatinine, eGFR, FFA, blood ketone body, AST, ALT, gamma-GTP, BUN, apolipoprotein) 19. Other urine test item (general urine test, microalbuminuria, urinary glucose, urinary ketone body, urinary Na, urinary K, urinary Cl, urinary creatinine, eGFR) 20. Body weight, blood pressure, heart rate, BMI, body composition (body fluid, bone mass, muscle mass, amount of fat, body fat percentage, basal metabolism quantity) 21. Chang in amount of meal consumed and the meal contents (BDHQ BOX) 22. Medication adherence rate (using medication adherence diary) 23. Occurrence rate of adverse events | — |
Countries
Japan
Outcome results
None listed