Comparison of safety and efficacy of Tofogliflozin and Ipragliflozin in patients with type 2 diabetes

Not Applicable

• Conditions: type 2 diabetes

• Registration Number: JPRN-UMIN000037158
• Lead Sponsor: Minami Osaka hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-26
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients who have a history of severe ketosis, diabetic coma or pre-coma within 6 weeks of study start. 2.Patients who developed severe hypoglycemia (diabetic coma or pre-coma, convulsions, etc. require assistance by a third party) within 6 weeks of study start. 3.Patients who have a history of medically important renal diseases such as renal vascular occlusive disease, nephrectomy and renal transplantation. 4.Patients who show symptoms of dysuria, anuria, oliguria or urinary retention 5.Patients who developed urinary tract infections and genital infections with subjective symptoms within 6 weeks of the study start. 6. Patients with proliferative retinopathy (however, patients with photocoagulation etc. who have stable symptoms can be included). 7. Patients with severe gastrointestinal disorders within 2 weeks of the study, or patients with a history of severe gastrointestinal disorders. 8.Patients with acute coronary syndrome, cerebrovascular disorder within 3 months. 9. Women and lactating patients who may or may be pregnant. 10. Patients with severe infections, before and after surgery, with serious trauma. 11. Patients receiving systemic administration of corticosteroids. 12.Patients who have severe liver dysfunction (a high level of AST or ALT of at least 100 U / L). 13.Patients who have a history of allergies to the drugs intended for the study. 14. Patients with a malignant tumor or a history of malignant tumor. 15.Patients judged by the investigator as inappropriate as subjects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of time less than 70 mg/dl (low blood glucose area) of continuous glucose monitoring (CGM)

Secondary Outcome Measures

Name	Time	Method
The percentage of time of the glucose level of hyperglycemic area (180 mg/dl or more), euglycemic area (70-179 mg/dl), hypoglycemic area (less than 70 mg/dl), severe hypoglycemic area (less than 54 mg/dl) and nighttime (0 : 00-5: 59) hypoglycemic area in CGM. Nighttime average blood glucose (0:00-5:59), daytime average blood glucose (6:00-23:59), blood glucose level 2 hours after every meal, 24-hour average blood glucose level, SD value, CV value, daily variation , M value, MAGE, urine glucose (0:00-7:30, 7:30-23:59), urine volume (0:00-7:30, 7:30-23:59).