Long-term comparison of luseogliflozin vs sitagliptin for Type 2 diabetes mellitus patients with NASH/NAFLD

JRCT ID: jRCTs031190238

Registered date:03/03/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus with NAFLD/NASH
• Date of first enrollment: 26/08/2020
• Target sample size: 210
• Study type: Interventional

Intervention(s)

Group A: Luseogliflozin hydrate 2.5 mg are orally administered once a day before breakfast or after breakfast for 72 weeks. If blood glucose control is insufficient, the dose can be increased to 5 mg once a day.
Group B: Sitagliptin Phosphate Hydrate 50 mg are orally administered once a day for 72 weeks. If glycemic control is insufficient, the dose can be increased up to 100 mg / day.

Outcome(s)

• Primary Outcome: Difference from baseline in MRE value at 72 weeks after administration

Secondary Outcome

1) Changes in hepatic steatosis at 24 weeks after administration (assessed by MRI-PDFF)
2) Liver disease-related events at 72 weeks after administration: presence of cirrhosis and liver carcinogenesis
3) Presence of cardiovascular events and other organ carcinogenesis at 72 weeks after administration
4) Changes from baseline in the clinical examination items at 24, and 72 weeks after administration
5) Changes from baseline in body weight, BMI and waist circumference at 12, 24, 48, 72 weeks after administration
<Safety evaluation items>
Frequency of adverse events and diseases

Key inclusion & exclusion criteria

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

Include criteria

1) male and female, aged 20-80 years. (Regardless of hospitalization or outpatient)
2) Diagnosed as type 2 diabetes mellitus, with HbA1c>=6.5% or prescribed diabetes medication during the screening period
3) Patients who diagnosed with fatty liver by abdominal ultrasonography
4) MRI-PDFF>=5.0 % steatosis, and MRE>=2.5 kPa
5) Alcohol consumption less than 30 g/day ethanol for males or 20 g/day ethanol for females
6) Patients who provide written consent to participate in the trial of their own free will.

Exclude criteria

1) Patients who diagnosed with type 1 diabetes or anti-GAD antibody positive
2) Patients with the following contraindications listed in the package insert of Luseogliflozin hydrate or Sitagliptin phosphate hydrate, and patients with a history of hypersensitivity to the ingredients of these drugs
-Patients with severe ketosis, diabetic coma or precoma, type 1 diabetes
-Patients with severe infections, before and after surgery, and severe external wounds
3) Patients with other liver diseases such as hepatitis C, hepatitis B (excluding inactive carriers), autoimmune hepatitis,primary biliary cholangitis, or with a history of hepatitis C (exclude cases 36 months or more after confirming virus negative)
4) BMI<18.5 kg/m2
5) Patients who are pregnant, breastfeeding, or suspected of being pregnant
6) Patients who can not prevent conception during study period
7) Patients who can not undergo MRI
8) Patients with cancer (patients who have undergone definitive surgery or who have completed administration of anticancer drugs can be registered, and patients who are under observation and evaluation of malignant tumors are excluded), or with a history of liver cancer
9) HbA1c >=11.0 %
10) Patients diagnosed hepatic cirrhosis or MRE>=6.7 kPa
11) Patients with portal hyper tension (platelet <100,000/uL, varicose veins, ascites, encephalopathy, splenomegaly)
12) Total bilirubin> 2 x upper limit of JCCLS common reference value
13) Patients using SGLT2 inhibitors, DPP-4 inhibitors GLP-1 agonists, pioglitazon and insulin for 1 month before registration
14) Patients with mental illness, alcoholism or drug addiction that may affect adherence to the research plan
15) Patients who are ineligible in the opinion of the investigator

Related Information

• Primary Sponsor: Kobayashi Takashi
• Secondary Sponsor: Sumida Yoshio
• Source(s) of Monetary Support: Taisho Pharmaceutical Co., Ltd.