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To Evaluate the Effect of Nesinaact on Non-alcoholic Steatohepatitis Through MRI and Liver Fibroscan in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03950505
Recruitment Status : Unknown
Verified October 2020 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : May 15, 2019
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:
This study was designed to evaluate the effect of Nesinaact on non-alcoholic steatohepatitis through magnetic resonance imaging (MRI)-based proton density-fat fraction (MRI-PDFF) and liver fibroscan in patients with type 2 diabetes. This is a prospective, open-label, single-arm, single-center clinical Study. After 24 weeks of Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment, the improvement of parameters estimated by MRI and liver fibroscan will be estimated.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Type2 Diabetes Drug: Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective, open-label, single-arm, single-center clinical Study. All participants will be treated with Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) for 24 weeks.
Masking: None (Open Label)
Masking Description: No masking is applied, as this is an open label study
Primary Purpose: Treatment
Official Title: To Evaluate the Effect of Nesinaact on Non-alcoholic Steatohepatitis Through MRI and Liver Fibroscan in Patients With Type 2 Diabetes: A Prospective, Open-Label, Single-Arm, Single-Center Clinical Study
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks
 Drug: Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks
All participants will be treated with Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) for 24 weeks. Patients who have not been prescribed any other anti-diabetic drugs at least for 12 weeks and whose HbA1c ranges from 6.5~8.5%, can be enrolled. If Patients has been prescribed metformin as monotherapy, they have to substitute metformin with nesinaact 25-15 for enrollment.


Outcome Measures
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Primary Outcome Measures :
  1. A degree of liver steatosis [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    Magnetic resonance imaging (MRI)-based proton density-fat fraction (MRI-PDFF) will be evaluated to confirm the improvement in liver steatosis.

  2. A degree of liver fibrosis [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    In liver fibroscan, liver stiffness (kPa) as a marker of fibrosis and CAP (dB/m) as a marker of steatosis will be estimated.


Secondary Outcome Measures :
  1. Clinical glucometabolic parameters : HbA1c [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    HbA1c in %

  2. Clinical glucometabolic parameters : Lipid parameters [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    Total cholesterol in mg/dL

  3. Clinical glucometabolic parameters : Lipid parameters [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    Triglyceride in mg/dL

  4. Clinical glucometabolic parameters : Lipid parameters [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    HDL-cholesterol in mg/dL

  5. Clinical glucometabolic parameters : Lipid parameters [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    LDL-cholesterol in mg/dL

  6. Clinical glucometabolic parameters : Liver enzymes [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    AST in IU/L

  7. Clinical glucometabolic parameters : Liver enzymes [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    ALT in IU/L

  8. Clinical glucometabolic parameters :Anthropometric parameters [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    Blood pressure in mmHg

  9. Clinical glucometabolic parameters :Anthropometric parameters [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    Body weight in kilogram

  10. Clinical glucometabolic parameters :Anthropometric parameters [ Time Frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment ]
    Body mass idex in kg/m2


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients ages >= 20 years

  2. Patients diagnosed with non-alcoholic fatty liver disease (NAFLD).

    => Definition of NAFLD: CAP (Controlled attenuation parameter) >= 250 dB/m

  3. Diabetic patients who meet one of the following glycemic conditions:

    • Patients with glycated hemoglobin (HbA1c) ranging 6.5~8.5 % while not taking an antidiabetic for more than 12 weeks irrespective of duration of diabetes.
    • Patients with HbA1c ranging 6.5~9.0 % in screening while using metformin monotherapy for more than 8 weeks without changing the dose irrespective of duration of diabetes.

Exclusion Criteria:

  1. Patients who meet the criteria for alcoholic liver disease whose alcohol intake for the recent tow years if above 210 g per week in men and above 140 g per week in women)
  2. Patients with chronic hepatitis B, C, or type 1 diabetes, or secondary diabetes
  3. Patients with history of acute or chronic metabolic acidosis and ketoacidosis, including diabetic ketoacidosis accompanied or not accompanied by coma
  4. Patients who were administered an oral hypoglycemic agent or insulin other than metformin within 8 weeks prior ro screening, or are likely to be administered it during the study duration among patients receiving monotherapy.
  5. Patients who had hypersensitivity to biguanide or glitazone in the past.
  6. Patients who received oral or parenteral corticosteroid treatment chronically (for more than 14 consecutive days) within 8 weeks prior to screening
  7. Patients wih past history of lactic acidosis
  8. Patients with a genetic disorder, such as galactose intolerance, Lapp lactase deficiency or glucose-galactose impaired absorption, etc.
  9. Patients wih malnutrition, starvation, weakness, (Including patients with severe infection), pituitary insufficiency or adrenal insufficiency
  10. Patients who have been receiving radiotherapy or chemotherapy due to bladder cancer and other malignant tumor, or it is less than 2 years since the patients received it.
  11. Patients with past history of bladder cancer
  12. A patient with history of drug abuse or alcoholism in 12 weeks
  13. A patient who has hear failure (NYHA class 3~4) or uncontrolled arrhythmia within 6 months
  14. A patient who has acute cardiovascular disease within 12 weeks (including unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass, or coronary intervention)
  15. A person who falls under one of the followings:

1) A patient with serum creatinine level >= 1.5 mg/dL in men and 1.4 mg/dL in women or a patient wih moderate to severe renal impairment (creatinine clearance: < 50 ml/min) 2) An anemia patient with 10.5 g/dL of Hb level

  • A pregnant or nursing woman
  • A patient who does not consent to use a proper method of contraception during the study period only among women or men of childbearing age
  • A patient who has taken investigational drug in other clinical study within 4 weeks following informed consent
  • A person who may not participate in the study according to investigator's judgement
  • A person who cannot read the informed consent form (e.g: an illiterate, a foreigner, etc.)
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): NCT03950505


Locations
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Korea, Republic of
Division of Geriatrics, Department of Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Kwang Joon Kim, MD, Ph.D    +82-2-2228-0960    PREPPIE@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03950505    
Other Study ID Numbers: 4-2018-0203
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Pioglitazone
 Alogliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action