The Japanese Study for Efficacy of Luseogliflozin on composite Endpoint, Compared to DPP-4 inhibitors, in Type 2 diabetes mellitus patients

JRCT ID: jRCTs031180241

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 17/02/2018
• Target sample size: 1000
• Study type: Interventional

Intervention(s)

Group A: Administration of luseogliflozin
Group B: Administration of DPP-4 inhibitors

Outcome(s)

Primary Outcome

Proportion of patients who improved three or more endpoints among five endpoints listed below from baseline to week 52 (proportion of patients who achieved the composite endpoints)
HbA1c (change from baseline =< -0.37%)
Body weight (percent change from baseline =< -3%)
eGFR (percent change from baseline >= -2.2%)
Blood pressure (change from baseline =< -4 mmHg)
Pulse (change from baseline =< -3 bpm)

Secondary Outcome

1.Proportion of patients who achieved the composite endpoints from baseline to week 24
2.Change in HbA1c from baseline
3.Change in body weight from baseline
4.Change in eGFR from baseline
5.Change in blood pressure from baseline
6.Change in pulse from baseline
7.Change in blood test values (or percent change in lipid biomarker values) from baseline
- lipid biomarkers: HDL-chol, T-chol, LDL-chol, TG
- hepatic biomarkers: AST, ALT, gamma-GTP
- others: blood count (red blood cell, hemoglobin, hematocrit, leukocyte, platelet), uric acid, Amy
8.change in specific test values from baseline
- blood test values: NT-proBNP, erythropoietin, reticulocyte
- urine test values: urinary albumin/creatinine ratio, urinary creatinine
9.change in OHA-Q (questionnaire for patients QOL) score from baseline
10.change in waist circumference and BMI from baseline
11.frequency of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study.
1.Patients with type 2 diabetes mellitus
2.Male and female aged 20 years or older and younger than 75 years when giving their consent
3.Patients who did not use antidiabetic medication within 8 weeks before consenting, or patients who used anti-diabetic therapeutic agents** other than SGLT2 inhibitors and DPP-4 inhibitors* and who did not change the usage and the dose of them within 8 weeks before consenting.
* including once-weekly DPP-4 inhibitors.
**Patients who use SU can be included in the study, if the patients meet all of the followring criteria.
i) Patients who regularly receive medical consultation more than once per month within 3 months before consenting.
ii) Patients whose HbA1c was continuously 7.5% or higher within 3 months before consenting.
iii) Patients who were considered not to have hypoglycemia within 3 months before consenting.
iv) Patients who use glimepiride of 2 mg/day or less, or gliclazide of 40 mg/day or less
4.Patients with HbA1c 6.5% or higher but no more than 10.0% within 12 weeks before consenting.
5.Patients who can give their consent in a written form

Exclude criteria

Patients who fall into any of the following criteria are excluded from participating in the study.
1.Type 1 diabetes mellitus or secondary diabetes
2.Patients who used insulin or GLP-1 analogs within 8 weeks before consenting
3.Patients who had myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent
4.Patients with severe liver disease (Patients with AST or ALT value five times or more of the upper limit of the stand value in each research institution)
5.Patients with serious renal disease (eGFR less than 30 mL/min/1.73m2)
6.Patients with unstable hypertension and dyslipidemia
7.Dehydrated patients (patients complain to have a symptom of dehydration)
8.Patients with urinary tract infection or genital infection
9.Patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant
10.Contraindication: patients with hypersensitivity to any medical component of each study drug
11.Patients who need legal representative for giving consent
12.Patients aged 65 years or older and 74 years or younger with geriatric syndrome (sarcopenia, cognitive dysfuncition, ADL impairment, etc.)
13.Patients with other conditions that the investigator/researcher thinks inappropriate for the study

Related Information

• Primary Sponsor: Sugawara Masahiro

Secondary Sponsor

Japan Society for Patient Reported Outcome
Soiken Inc.

• Secondary ID(s): UMIN000030128