Combination of SGLT2 inhibitor and Intensive Exercise in Diabetes.

Not Applicable

• Conditions: type 2 diabetes

• Registration Number: JPRN-jRCTs071180050
• Lead Sponsor: Yoshihiro Ogawa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified