Sodium glucose cotransporter inhibitor 2, Tofogliflozin versus glimepiride, comparative trial in Patients with type 2 diabetes On Body composition (STOP-OB study)

Not Applicable

• Conditions: Type 2 Diabetes

• Registration Number: JPRN-UMIN000026161
• Lead Sponsor: Japan society for Patient Reported Outcome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients with type 1 diabetes or secondary diabetes 2. Patients who have used antidiabetic medication other than DPP-4 inhibitors or metformin (e.g. insulin, GLP-1 receptor agonist) within the 12 weeks until consenting 3. Patients who have changed the dosage of a diuretic agent or started a new diuretic agent within the 12 weeks until consenting 4. Patients with BMI below 18.5 kg/m2 or BMI 35 kg/m2 or higher at the time of consenting 5. Patients with conditions contraindicated the use of study drugs 6. Patients with a medical history of hypersensitivity to the study drugs 7. Patients with moderate to severe renal function impairment, or at the terminal stage of renal failure (eGFR< 60mL/min/1.73m2) 8. Patients with severe hepatic impairment 9. Patients with a medical history of stroke or cerebral infarction 10. Patients who are currently or possibly pregnant, breastfeeding or planning to be pregnant 11. Patients with moderate to severe heart failure (New York Heart Association [NYHA] functional class III or higher) 12. Patients with urinary tract infection or genital infection 13. Patients currently with a malignancy, or with a medical history of a malignancy (excluding those who are not currently treated for the malignancy or show no redevelopment of it, or a physician assures no relapse during the study period) 14. Patients with other conditions that investigators/physicians think inappropriate to join the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified