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Non-alcoholic SteatohepatitisPhase 4NCT03950505

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

A Phase 4 study testing Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks in people with Non-alcoholic Steatohepatitis and Type2 Diabetes, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Non-alcoholic Steatohepatitis, Type2 Diabetes
What is being tested?
Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
29 May 2020to Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ages >= 20 years
  • Patients diagnosed with non-alcoholic fatty liver disease (NAFLD).
  • => Definition of NAFLD: CAP (Controlled attenuation parameter) >= 250 dB/m
  • 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.

Who cannot join

  • 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)
  • Patients with chronic hepatitis B, C, or type 1 diabetes, or secondary diabetes
  • Patients with history of acute or chronic metabolic acidosis and ketoacidosis, including diabetic ketoacidosis accompanied or not accompanied by coma
  • 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.
  • Patients who had hypersensitivity to biguanide or glitazone in the past.
  • Patients who received oral or parenteral corticosteroid treatment chronically (for more than 14 consecutive days) within 8 weeks prior to screening
Show all 21Show fewer
  • Patients wih past history of lactic acidosis
  • Patients with a genetic disorder, such as galactose intolerance, Lapp lactase deficiency or glucose-galactose impaired absorption, etc.
  • Patients wih malnutrition, starvation, weakness, (Including patients with severe infection), pituitary insufficiency or adrenal insufficiency
  • 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.
  • Patients with past history of bladder cancer
  • A patient with history of drug abuse or alcoholism in 12 weeks
  • A patient who has hear failure (NYHA class 3~4) or uncontrolled arrhythmia within 6 months
  • 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)
  • 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.)

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Division of Geriatrics, Department of Internal Medicine, Yonsei University College of Medicine

    Seoul

    Kwang Joon Kim, MD, Ph.D, +82-2-2228-0960, PREPPIE@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

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

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.

Being tested
Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeksDrug

    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.

Study groups in NCT03950505
Study groupRoleWhat they receive
1ExperimentalNesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks
Receives: Drug: Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A degree of liver steatosis

    Magnetic resonance imaging (MRI)-based proton density-fat fraction (MRI-PDFF) will be evaluated to confirm the improvement in liver steatosis.

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

  2. A degree of liver fibrosis

    In liver fibroscan, liver stiffness (kPa) as a marker of fibrosis and CAP (dB/m) as a marker of steatosis will be estimated.

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

Secondary outcomes (10)

  1. Clinical glucometabolic parameters : HbA1c

    HbA1c in %

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

  2. Clinical glucometabolic parameters : Lipid parameters

    Total cholesterol in mg/dL

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

  3. Clinical glucometabolic parameters : Lipid parameters

    Triglyceride in mg/dL

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

  4. Clinical glucometabolic parameters : Lipid parameters

    HDL-cholesterol in mg/dL

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

  5. Clinical glucometabolic parameters : Lipid parameters

    LDL-cholesterol in mg/dL

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

  6. Clinical glucometabolic parameters : Liver enzymes

    AST in IU/L

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

  7. Clinical glucometabolic parameters : Liver enzymes

    ALT in IU/L

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

  8. Clinical glucometabolic parameters :Anthropometric parameters

    Blood pressure in mmHg

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

  9. Clinical glucometabolic parameters :Anthropometric parameters

    Body weight in kilogram

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

  10. Clinical glucometabolic parameters :Anthropometric parameters

    Body mass idex in kg/m2

    Measured: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2019
  2. Study start29 May 2020
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03950505
Sponsor's protocol ID
4-2018-0203
Status last verified
Oct 2020
First submitted
8 May 2019
Last updated
9 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks in people with Non-alcoholic Steatohepatitis and Type2 Diabetes, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A degree of liver steatosis (time frame: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03950505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.

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