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Clinical Trial Details

Trial ID: L7059
Source ID: NCT03950505
Associated Drug: Nesinaact 25/15 (Alogliptin Benzoate 25mg, Pioglitazone Hydrochloride 15mg) Treatment For 24 Weeks
Title: To Evaluate the Effect of Nesinaact on Non-alcoholic Steatohepatitis Through MRI and Liver Fibroscan in Patients With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Non-alcoholic Steatohepatitis|Type2 Diabetes
Interventions: DRUG: Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks
Outcome Measures: Primary: 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 | Secondary: 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, 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
Sponsor/Collaborators: Sponsor: Yonsei University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-05-29
Completion Date: 2020-12
Results First Posted:
Last Update Posted: 2020-10-09
Locations: Division of Geriatrics, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03950505

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