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

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ClinicalTrials.gov Identifier: NCT02875821
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes With Non-alcoholic Fatty Liver (NAFLD) Drug: Ipragliflozin Drug: metformin with pioglitazone Phase 4

Detailed Description:

Pioglitazone, a peroxisome proliferator-activated receptor-γ (PPARγ) agonist increase insulin sensitivity in peripheral tissue and liver by protecting non-adipose tissues against excessive lipid overload and by balancing the secretion of adipocytokines.

However, PPARγ is a key transcription factor that induces the differentiation adipocyte maturation and stimulates the induction of enzymes involved in lipogenesis. As a result, the effect of pioglitazone is generally accompanied by weight gain and an increase in amount of subcutaneous fat.

Obesity would coexist with fatty liver disease and both conditions aggravate hyperglycemia in diabetes. According to recent study, up-regulated PPARγ expression in liver was reported in obesity with hepatic steatosis which implies pioglitazone might induce fatty liver disease.

A novel oral antidiabetic drug, sodium glucose cotransporter 2 (SGLT2) inhibitor reduces renal glucose reabsorption and increasing renal glucose excretion thereby promoting energy loss. As a result, it prevents weight gain and fluid retention which might counteract the unfavorable effects of pioglitazone treatment.

No study has been conducted on the additional effect on obesity and fatty liver of ipragliflozin in T2DM patients treated with pioglitazone and metformin.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : April 26, 2016
Actual Primary Completion Date : June 7, 2017
Actual Study Completion Date : June 7, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group IMP
Group IMP (Ipragliflozin with Metformin with Pioglitazone)
 Drug: Ipragliflozin
Patients treated with ipragliflozin (50 mg/day) as add on therapy to metformin and pioglitazone dual therapy (triple therapy) for 6 months. During whole periods of study, subjects are educated for nutrition and exercise. (Experimental Group)
Other Name: Suglat®
Active Comparator: Group MP
Group MP (Metformin with Pioglitazone)
 Drug: metformin with pioglitazone
Patients maintain metformin and pioglitazone dual therapy for 6 months. During whole periods of study, subjects are educated for nutrition and exercise. (Control group)


Outcome Measures
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Primary Outcome Measures :
  1. changes in visceral fat area [ Time Frame: 6 months ]
    The visceral fat area is measured by dual-energy x-ray absorptiometry (DEXA) at baseline and after 6 months treatment


Secondary Outcome Measures :
  1. Changes in subcutaneous fat area [ Time Frame: 6 months after treatment ]
    The subcutaneous fat area is measured by dual-energy x-ray absorptiometry (DEXA) and fat computed tomography (CT) at baseline and after 6 months treatment.

  2. Changes in liver fat [ Time Frame: 6 months after treatment ]
    Changes in the degree of fatty liver is measured by fibroscan using controlled attenuation parameter (CAP) score.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875821


Locations
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Korea, Republic of
Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02875821    
Other Study ID Numbers: 4-2015-1115
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
 Digestive System Diseases
Metformin
Pioglitazone
Ipragliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action