Efficacy and safety of the combination therapy with Ipragliflozin for the cases who have insufficient effect by oral hypoglycemic agents

Not Applicable

• Conditions: type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000016563
• Lead Sponsor: ational Hospital Organization Kyoto Medical Center

Brief Summary

The patients' diminished estimated glomerular filtration rate (eGFR) was alleviated in the ipragliflozin group compared to the control group prior to significant improvements in HbA1c and other parameters, including anthropometric indices and arterial stiffness. Furthermore, ipragliflozin add-on therapy resulted in a greater reduction in serum UA levels than control therapy. The changes in the eGFR with ipragliflozin treatment were associated with ipragliflozin-mediated changes in the UA.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-17
• Study Completion: 2016-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

1.Type 1 diabetes mellitus 2.Subjects with severe ketosis, diabetic coma or precoma 3.Subjects with severe infection, before and after surgery or severe injury 4.Subjects with severe hepatic dysfunction 5.Subjects with moderate renal dysfunction (Serum creatinine: more than 1.5mg/dL in male, more than 1.3mg/dL in female) 6.The subjects within the past 6 months, developed stroke, myocardial infarction, or other serious vascular complications requiring hospitalization 7.Sunjects with dehydration, diarrhea, vomiting or gastrointestinal injury 8.Subjects in SGLT-2 inhibitors, insulin formulation, GLP-1 receptor agonist prescription 9.Subjects in pregnant women, lactating women, the potential or planned are pregnant 10.Subjects with a history of hypersensitivity to SGLT-2 inhibitor 11.Subjects who have been determined to be unsuitable for the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c

Secondary Outcome Measures

Name	Time	Method
fasting plasma glucose, body weight, blood pressure, waist circumference, body mass index, muscle mass, subcutaneous fat area size, visceral fat area size, cardio ankle vascular index, serum cystatin-C, urinary cystatin-C, SAA-LDL, leptin, adiponectin, high sensitive CRP