Combination Therapy of SGLT2 Inhibitor and intensive Physical Exercises, focusing on the Prevention of Muscle Mass Reduction in Patients with Type 2 Diabetes - Combination of SGLT2 inhibitor and Intensive Exercise in Diabetes.

Yoshihiro Ogawa0 个研究点目标入组 146 人开始时间: 2019年3月15日最近更新: 2023年10月17日

试验速览

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•1)Type 2 diabetic patients with age of 20 years old or older but below 75 years old
•2)Patients whose BMI is 18.5 kg/m2 or higher but below 35.0 kg/m2
•3)Patients whose HbA1c is 6.5% or higher but below10.0% (examination values of week 0 are to be applicable)
•4)Patients whose eGFR is 45 mL/min/1.73 m2 or higher
•5)Patients who have been receiving medications without any change in the administration and dosage for more than 8 weeks prior to the registration
•6)Patients who can abide by the designated dietary treatment and exercise therapy
•7)Patients from whom a consent in writing for the participation in this study has been obtained in person

•1) Type 1 diabetic patients
•2) Patients with a medical history of hypersensitivity to some ingredient(s) of the SGTL2 Inhibitor
•3) Patients suffering from severe ketosis, diabetic coma, or precoma
•4) Patients with severe infections, patients before or after operations or having severe external injuries
•5) Patients with severe renal dysfunction, or patients with end-stage renal disease or those undergoing dialysis
•6) Patients with severe liver dysfunction
•7) Patients who are highly likely to suffer from dehydration
•8) Patients with pituitary gland dysfunction or adrenal gland dysfunction
•9)Patients in dystrophia conditions, starvation status, irregular meal intake, insufficient dietary intake, or extremely weakened state
•10) Patients with an excessive alcohol consumption
•11) Pregnant women, patients who might be pregnant, and lactating women
•12) Patients with active infectious diseases
•13) Patients with malignancies
•14)Patients with active diabetic proliferative retinopathy
•15) Patients with glucocorticoid
•16) Patients with insulin
•17)Patients who have experienced hypoglycemia 3 times or more, which requires a drug treatment such as instillation with glucose before recovery
•18) Patients who are judged to be inadequate to participate in this study by a doctor in charge

发起方

Yoshihiro Ogawa