Prospective observational study of tofogliflozin in patients with type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes

• Registration Number: JPRN-jRCT1090220212
• Lead Sponsor: agoya Medical Association

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-08
• Study Completion: 2019-01-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

*Patients with type 2 diabetes
*Age 20 years or older
*The patients that diabetes treatment does not have a change more than the past two months
* In more than 6.0% and regulation are less than +-10% of patients each HbA1c of most recent two times
*Ability to give written informed consent

Exclusion Criteria

*Patients with type 1 diabetes
*History of severe ketosis, diabetic coma or previous coma within 6 months
*Patients with severe infectious disease ,before or after surgery, or sever trauma
*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 tofogliflozin
*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 12months<br>*Number of adverse events

Secondary Outcome Measures

Name	Time	Method
Change in the amount or ratio of the following biomakers from baseline to 3 months,12 months: <br>*HbA1c (except in the case of 12 months), Blood glucose level,*Body weight and waist circumference,<br>*Serum lipid level (TC, TG, HDL-C),*Blood pressure <br>*Renal function (eGFR, BUN, Serum creatinine)