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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| 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. | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical glucometabolic parameters : HbA1c | HbA1c in % | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| Clinical glucometabolic parameters : Lipid parameters |
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Inclusion Criteria:
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:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Geriatrics, Department of Internal Medicine, Yonsei University College of Medicine | Recruiting | Seoul | South Korea |
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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.
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No masking is applied, as this is an open label study
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|
Total cholesterol in mg/dL
| 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| Clinical glucometabolic parameters : Lipid parameters | Triglyceride in mg/dL | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| Clinical glucometabolic parameters : Lipid parameters | HDL-cholesterol in mg/dL | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| Clinical glucometabolic parameters : Lipid parameters | LDL-cholesterol in mg/dL | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| Clinical glucometabolic parameters : Liver enzymes | AST in IU/L | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| Clinical glucometabolic parameters : Liver enzymes | ALT in IU/L | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| Clinical glucometabolic parameters :Anthropometric parameters | Blood pressure in mmHg | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| Clinical glucometabolic parameters :Anthropometric parameters | Body weight in kilogram | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| Clinical glucometabolic parameters :Anthropometric parameters | Body mass idex in kg/m2 | 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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