Effects of Ipragliflozin on Excessive Fat in Type 2 Diabetes Patients With Non-alcoholic Fatty Liver Disease Treated With Metformin and Pioglitazone

• Status: Completed
• Trial end date: 2017-06-07
• Target enrollment: 0
• Participant gender: All

Summary

In this study, the investigators investigate beneficial effects of ipragliflozin, newly developted SGLT2 inhibitor, on reduction in visceral fat area and degree of fatty liver in subjects with T2DM when added to metformin and pioglitazone therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Ipragliflozin; Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• Type 2 diabetic patients

• Diagnosed as NAFLD

• Age of 20~75

• On metformin + pioglitazone treatment with stable dose for at least 8 weeks

• Adequate glycemic control: HbA1c ≤ 9.5%

• Overweight & obese: BMI ≥ 23 kg/m2

• Subject is male, or subject is female who is highly unlikely to conceive

• Understands the study procedure, alternatives, and risks and voluntarily agrees to participate by giving written informed consent

Exclusion Criteria:

• Type 1 diabetes, Secondary diabetes, gestational diabetes

• Heavy alcoholics (men ≥210 g of alcohol per week, women ≥140 g of alcohol per week)

• Underlying chronic liver disease (hemochromatosis, liver cell carcinoma, autoimmune liver disease, liver cirrhosis, chronic viral hepatitis [except hepatitis B carrier], Wilson's disease)

• Patients on medication causes hepatic steatosis (e.g.amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc)

• Allergy or hypersensitivity to target medication or any of its components

• Renal failure, moderate or severe renal impairment (estimated glomerular filtration rate < 60 mL/min/1.73 m2), or ongoing dialysis

• Abnormal liver function (AST/ALT > x10 upper normal limit)

• On taking weight loss medication

• History of alcohol or drug abuse in the previous 3 months

• Premenopausal women who are nursing or pregnant

• Human immunodeficiency virus (HIV) or human immunodeficiency virus (AIDS)

• Diabetic ketoacidosis

• Severe infection, severe trauma