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

JRCT ID: jRCTs061190008

Registered date:24/06/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 10/07/2019
• Target sample size: 114
• Study type: Interventional

Intervention(s)

Luseogliflozin group: administer 2.5 mg of luseogliflozin orally before or after breakfast
Teneligliptin group: administer 20 mg of teneligliptin orally before or after breakfast

Outcome(s)

• Primary Outcome: Change in Disposition Index((Delta Ins 0-120 / Delta Glu 0-120) x (Matsuda index)) from base line to week 25-26 (after week 1-2 of washout period)

Secondary Outcome

1.Change in Disposition Indexes other than primary outcome ((Delta Ins 0-30 / Delta Glu 0-30) x (Matsuda index), (AUCIns / AUCGlu) x (Matsuda index))
2.Change in proinsulin, proinsulin/CPR ratio, and proinsulin/insulin ratio
3.Change in HbA1c
4.Change in oral glucose tolerance test biomarkers (plasma glucose, insulin, proinsulin, C-peptide)
5.Change in specific blood test biomarkers (NEFA, adiponectin, MDA)
6.Change in General blood tests (plasma glucose, ketone body fraction (venous blood), lipid biomarkers (HDL-chol, T-chol, LDL-chol, TG), hepatic function biomarkers (T-Bil, AST, ALT, gamma-GTP), blood count (red blood cell, hemoglobin, hematocrit, leukocyte, platelet), uric acid, serum creatinine
7.Change in urine tests (urinary albumin, urinary creatinine)
8.Change in blood pressure, body weight, BMI, and body compositions
9.Change in skin AGEs
10.Medication adherence
11.Frequency of adverse events, diseases or the like

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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)
10.patients with urinary tract infection or genital infection
11.patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant
12.patients with hypersensitivity or contraindication to any medical component of each study drug
13.patients currently with a malignancy, or with a medical history of a malignancy (excluding those who are not currently treated for the malignancy or show no redevelopment of it, or a physician assures no relapse during the study period)
14.patients who are considered to be unsuitable for participation by investigators

Related Information

• Primary Sponsor: Kaneto Hideaki
• Source(s) of Monetary Support: Taisho Pharmaceutical Co., Ltd.