Type 2 diabetes
Conditions
Interventions
Orally administration of 50 mg sitagliptin once a day, pre or post breakfast for 12 weeks
Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 12 weeks
Sponsors
Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
1) Physical Checkup Depertment, Yokohama Rosai Hospital 2) Matsuo Naika Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged from 20 to 75 years at providing consent 2) HbA1c >= 6.5% 3) BMI >= 23 kg/m2 4) Provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes 2) Is receiving DPP-4 inhibitor, SGLT-2 inhibitor at providing consent 3) Is receiving insulin therapy at providing consent 4) Poorly controlled patients with metabolic acidosis, etc 5) Has history of severe ketosis, diabetic coma, or precoma 6) With severe infection, pre or post surgery, and serious trauma 7) Is pregnant or possibility of pregnant 8) With thyroid disorder 9) With autoimmune disease 10) With moderate or severe hepatic disorder or renal dysfunction 11) Has history of hypersensitivity to ipragliflozin, sitagliptin, any other excipient, or SGLT-2 inhibitor 12) Considered as inadequate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients for whom HbA1c decreases 0.5% or more and not increase in weight at 12 weeks after initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Change and percent change in following items from baseline to 12 weeks 1) Serum insulin (immunoreactive insulin) 2) HOMA-IR 3) HOMA-beta 4) Serum lipids 5) LPL (quantitative determination) 6) FFA (free fatty acids) 7) FABP (fatty acid binding protein) 8) P/I ratio (proinsulin/insulin ratio) 9) Serum glucagon 10) Serum ketone body 11) Body composition | — |
Countries
Japan
Contacts
Public ContactYUYA TSURUTANI
Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital Endocrinology and Diabetes Center
Outcome results
None listed