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Investigation for clinical efficacy and safety of ipragliflozin 50mg and 100mg on type 2 diabetes

Not Applicable
Conditions
Type 2 diabetes
Registration Number
JPRN-UMIN000016131
Lead Sponsor
Osaka Saiseikai Nakatsu Hospital Division of diabetes and endocrinology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
600
Inclusion Criteria

Not provided

Exclusion Criteria

1) Type 1 diabetes, patients with other types of diabetes or pregnancy diabetes 2) History of severe ketoacidosis diabetic coma or profound come within 6 months 3) Severe infection, perioperative or severe trauma 4) Moderate renal insufficiency(male >1.5mg/dL, female>1.3mg/dL) 5) Severe hepatic impairment 6) History of requirement of hospitalization for severe CV event within 6 months other 7) Patients with pregnancy, breast-feeding, childbearing potential or plan of pregnancy 8) Patients with neuropathic bladder or dysuria 9) Patients with treatment of diuretic drug 10) Patients with SGLT2 treatment at start of this study 11) Patients who has an episode of sensitivity of SGLT-2 12) Patients who are not eligible judged by investigator

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes of HbA1c at 52weeks treatment after initiation
Secondary Outcome Measures
NameTimeMethod
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