Prospective observational study of SGLT2 inhibitor, ipragliflozin in patients with type 2 diabetes
- Conditions
- Type 2 Diabetes
- Registration Number
- JPRN-jRCT1090220182
- Lead Sponsor
- General Incorporated Association Nagoya Medical Association
- Brief Summary
A supplementary administration of a ipragliflozin not only improved HbA1c but also showed weight loss, decreased blood pressure, improved liver function, and the higher HbA1c at initiation and ALT at onset, the lower HbA1c after administration of ipragliflozin It was also suggested that patients' effect prevention awareness is expected to be improved by using a patient questionnaire with a amount, suggesting that there is a possibility of suppressing the occurrence rate of side effects of ipragliflozin . From these observations, we believe that additional administration of a ipragliflozin can be a useful choice in the treatment of type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
*Patients with type 2 diabetes
*Age 20 years or older, but 75 or younger
*Patients with insufficiently controlled diabetes who are continuing diet therapy and/or exercise therapy or drug therapy
*HbA1c 6.0% or more, but less than 9.5%
*Ability to give written informed consent
*Patients with type 1 diabetes
*History of metabolic acidosis, severe ketosis, diabetic coma or total coma within 6 months
*Patients with severe infectious disease ,before or after surgery, or sever trauma
*Patients with moderate or severe renal dysfunction (serum creatinine level 1.5 mg/dL and more for male, 1.3 mg/dL and more for female)
*Occurrence of stroke, myocardial infarction or vascular complication required hospitalization within 6 months
*Under treatment with SGLT-2 inhibitors
*Pregnant, women on lactation or possibly pregnant women, or plan to pregnant during the study
*History of hypersensitivity to SGLT-2 inhibitors
*Ineligible patients according to the investigator's judgment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method *Change in HbA1c level from baseline to Week 24<br>*Number of hypoglycemic episodes and other adverse events
- Secondary Outcome Measures
Name Time Method Change in the amount or ratio of the following biomakers from baseline to Week 24:<br>*HbA1c (except in the case of Week 24), fasting serum glucose level, fasting serum insulin level, HOMA-beta and HOMA-R<br>*Body weight and waist circumference<br>*Serum lipid level (TC, TG, HDL-C, LDL-C and non-HDL-C)<br>*Blood pressure<br>*Renal function (eGFR, urinary and albumin)<br>*High molecular weight adiponectin and high sensitive CRP<br>*Medication adherence (from a questionnaire)