Effects of Ipragliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin Therapy
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000018839
- Lead Sponsor
- Shiga University of Medical Science
- Brief Summary
BW change was significantly larger in the ipragliflozin group than in the control group (-2.78 vs -0.22 kg, P < 0.0001). Total fat mass was reduced evenly in the arms, lower limbs and trunk in the ipragliflozin group. Total muscle mass and bone mineral content were maintained, but muscle mass in the arms might have been affected by ipragliflozin treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1) Has history of receiving a SGLT-2 inhibitor 2) Contraindication to the use of ipragliflozin (history of hypersensitivity to ipragliflozin, or pregnant, etc.) 3) With severe ketosis, diabetic coma, or precoma 4) Has history of hospitalization for infection, trauma, or surgery within 6 months 5) With history or under treatment of brain infarction or transient ischemic attack 6) With an episode of angina pectoris or myocardial infarction within 6 months 7) Receiving loop diuretics 8) With orthostatic hypotension 9) Considered as inadequate by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in body weight from 0 to 24 weeks
- Secondary Outcome Measures
Name Time Method