Type 2 diabetes
Conditions
Interventions
Orally administration of 50mg ipragliflozin once a day, pre or post breakfast for 24 weeks
Sponsors
Association of medical corporation Ouitsu-kai, Kanno-naika
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Japanese patient who meets all the following inclusion criteria 1) Type 2 diabetes patients with untreated or treated with hypoglycemic agent 2) 20 years and older 3) BMI >= 22kg/m2 4) HbA1c >= 6.5% 5) Received written informed consent
Exclusion criteria
Exclusion criteria: 1) With severe ketosis, history of diabetic or precoma, severe infection, pre or post surgery, and severe trauma, hypersensitivity to ipragliflozin or any other excipient of ipragriflozin 2) With hypophyseal dysfunction or adrenal insufficiency who have high possibility of induces hypoglycemia 3) With urinary tract or genital infection 4) With severe hepatic dysfunction 5) Is receiving SGLT-2 inhibitors at initiation of this study 6) Is nursing or pregnant or planned to become pregnant 7) Considered as inadequate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change and percent change in following items from baseline to 4 week, 12 week, and 24 week fasting plasma glucose HbA1c (Except for the change at 24 week) Body weight 2) Stratification analysis on efficacy of ipragliflozin Dietary composition with BDHQ (intake of carbohydrate and lipid) 3) Palatability change of diet (appetite, incentive to sugar, degree of acquisition desire) Comparison of ipragliflozin treated group with other medicated group | — |
Countries
Japan
Contacts
Public ContactKazuo Kanno
Association of medical corporation Ouitsu-kai, Kanno-naika Medical director
Outcome results
None listed