type 2 diabetes mellitus
Conditions
Interventions
Conventional treatment + Ipragliflozin [50mg/1day]
Conventional treatment
Sponsors
National Hospital Organization Kyoto Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Type 2 diabetes mellitus 2.The cases who has insufficient glycemic control for more than 12 weeks after the treatment oral hypoglycemic agents 3.BMI:more than 22 kg/m2 4.HbA1c:6.5% to less than 9.0% 5.Subject have a diet and exercise therapy 6.Outpatient
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNoriko Satoh-Asahara
National Hospital Organization Kyoto Medical Center Clinical Research Institute for Endocrine Metabolic Diseases
Outcome results
None listed