The Study of Effect of antidiabetic agents on pancreatic beta-Cell REsponsiveness To glucose; comparative Evaluation of DPP-4 Inhibitors and SGLT2 inhibitor, Luseogliflozin - SECRETE-I study

Kaneto Hideaki0 sites113 target enrollmentJune 24, 2019

ConditionsType 2 Diabetes Mellitus Diabetes Mellitus, Type 2 D003924

Overview

Phase: 未知
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Kaneto Hideaki
Enrollment: 113
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Both luseogliflozin and teneligliptin significantly improved beta-cell function in patients with type 2 diabetes who had not achieved the target for HbA1c value, and there were no significant differences in their effects. The improvement in beta-cell function was more pronounced in patients with inadequate insulin secretion in response to insulin resistance.

Registry

who.int

Start Date

June 24, 2019

End Date

May 21, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Kaneto Hideaki

Eligibility Criteria

Inclusion Criteria

•Patients meeting the following criteria will be included in the study.
•1\.patients with type 2 diabetes mellitus whose HbA1c is 7\.0% or higher and less than 9\.0%, despite diet and exercise therapy alone (drug\-naive) or anti\-diabetic agent treatment other than DPP\-4 inhibitors or SGLT2 inhibitors for 12 weeks or longer in addition to diet and exercise therapy
•2\.patients who do not start to use anti\-diabetic agent or who do not increase the dose of anti\-diabetic agent within 12 weeks before giving their consent
•3\.male and female aged \>\= 20 years and \< 80 years
•4\.patients whose body mass index (BMI) is 20 kg/m2 or higher
•5\.Patients who provide written consent form to participate in this study after full explanation of the study

Exclusion Criteria

•Patients meeting any of the following exclusion criteria will be excluded from the study
•1\.patients with type 1 diabetes mellitus
•2\.patients with diabetes mellitus which was caused by specific mode of action or diseases, such as exocrine pancreatic insufficiency, endocrine disorder, drug\-induced, or hereditary diseases
•3\.patients with diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome
•4\.patients who used insulin or GLP\-1 receptor agonist within 12 weeks before giving their consent
•5\.patients with history of myocardial infarction, cerebral stroke within 12 weeks before giving their consent
•6\.patients with severe infection, during a perioperative period, or with severe physical injury
•7\.patients with severe liver disease (patients with AST or ALT value five times or higher of the upper limit of the stand value in research institution)
•8\.patients with severe renal disease (eGFR of less than 30 mL/min/1\.73m2\)
•9\.patients with dehydration (patients who complain to have a symptom of dehydration)