Type 2 diabetes
Conditions
Interventions
Oral administration of 50 mg ipragliflozin once a day, pre or post breakfast for 52 weeks. The dose can be increased up to 100 mg if the effect is insufficient. Patients who satisfy the inclusion and
Sponsors
The Study Group of the Diabetes Committee, Kanagawa Physicians Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years and older at providing consent 2) Outpatients providing written informed consent 3) Male and Female 4) Initiating administration of ipragliflozin because of poorly controlled glucose level whereas undergoing diet/exercise therapy or additional hypoglycemic agent at least 12 weeks 5) HbA1c >= 6.0 % [Inclusion criteria for extension administration] Patients who satisfy 1)-5) and both of following conditions 6) Patients considered the extension treatment with ipragliflozin is required by investigator 7) Patients who agreed with extension treatment with ipragliflozin
Exclusion criteria
Exclusion criteria: 1) Has hypersensitivity to ipragliflozin or any other excipient of ipragliflozin 2) With severe ketosis, diabetic coma, or precoma within 6 months 3) With severe infection, pre or post surgery, and serious trauma 4) With severe renal dysfunction 5) Considered as inadequate by the investigator 6) Is pregnant or possibility of pregnant, planning or possibility of pregnant during research (Except for acceptable method of birth control, surgically sterilized, and postmenopause), or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in following items from baseline to 4, 12, 24, 36 and 52 weeks For patients receiving ipragliflozin after 52 weeks, change in following items and HbA1c from baseline to 78 and 104 weeks are also evaluated. 1) Change in fasting and postprandial glucose from baseline 2) Change in body composition from baseline 3) Change in body weight and waist circumference from baseline 4) Change in serum lipids, free fatty acid, and blood pressure from baseline 5) Improvement from baseline of HbA1c by patient characteristic at initiation | — |
Countries
Japan
Contacts
Public ContactIkuro Matsuba
Matsuba Medical Clinic Medical director
Outcome results
None listed