A 24 Week, Multicenter, Prospective, Open-labeled, Single-arm, Exploratory Phase 4 Clinical Trial to Evaluate the Safety and Efficacy of Lobeglitazone in Decreasing Intrahepatic Fat Contents in Type 2 Diabetes With NAFLD

NCT02285205 | Completed Phase 4

• 1 other identifier: 4-2014-0778
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It demonstrates that Lobeglitazone improves even more glycemic and lipid control in comparison to rosiglitazone and pioglitazone. Currently, thiazolidinediones such as pioglitazone is the only drug which is considered as an effective therapeutic agent for improving non-alcoholic fatty liver disease (NALFD) in type 2 diabetes (T2D). The aim of this multicenter, prospective, open-labeled, single-arm, exploratory phase 4 study is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on intrahepatic fat contents assessed by transient elastography (fibroscan) in T2D with NAFLD. Fifty subjects with T2D and NAFLD will take Lobeglitazone (0.5mg/tablet, orally, 1 tablet once daily) for 24 weeks. Primary endpoint is changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone. Secondary endpoints are changes from baseline in glycemic profiles (HbA1c, Glycated albumin), Lipid parameters (Total Cholesterol, Triglycerides, HDL-C, LDL-C), Liver function parameters (AST, ALT, r-GT), and adverse events during the trial.

Conditions

Type 2 Diabetes; Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• changes from baseline in controlled attenuation parameters (CAP)

  Changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone

  24 weeks

Study Arms (1)

Lobeglitazone

EXPERIMENTAL

Drug: Oral administration of Lobeglitazone

Interventions

Oral administration of Lobeglitazone DRUG

Lobeglitazone 0.5mg/tablet, orally, 1 tablet once daily for 24 weeks

Lobeglitazone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type Ⅱ diabetes mellitus
• Non-alcoholic fatty liver disease: subjects who have CAP(Controlled Attenuation Parameter) ≥ 250dB/m measured by transient elastography (fibroscan) at screening test
• Age ≥ 20 years
• Patients who have not been taking any oral hypoglycemic agent for more than 12 weeks with HbA1c 7.0 to 8.5% at screening test or who have been taking metformin monotherapy for at least 8 weeks with HbA1c 7 to 9% at screening test
• Agreement with written informed consent

You may not qualify if:

• Patients whose alcohol consumption \>210g/week for males and 140g/week for females
• chronic B viral hepatitis, chronic C viral hepatitis, Type I diabetes, or secondary diabetes
• having a history of acute or chronic metabolic acidosis including diabetic ketoacidosis
• patients who have been taking other oral hypoglycemic agents except metformin or insulin within recent 8 weeks
• who experienced hypersensitivity reaction against metformin or glitazone drugs
• who has been treated with corticosteroids for at least 14 days within 2 month prior to Screening
• having a history of lactic acidosis
• having genetic predispositions such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• who are in condition of malnutrition, starvation, cachexia, severe infection, major trauma, hypopituitarism, or adrenal insufficiency
• diagnosed with cancer within 2 years or having chemo or radiotherapy for cancer treatment
• a history of drug abuse or chronic alcoholism
• a history of heart failure (NYHA class III and IV) or uncontrolled arrhythmia
• a history of acute cardiovascular or cerebrovascular disease within 12 weeks prior to Screening (unstable angina, myocardial infarction, transient ischemic attack, cerebral infarct, cerebral hemorrhage, coronary bypass, percutaneous coronary intervention)
• Renal dysfunction: Serum creatinine greater than 1.5mg/dl for males and 1.4mg/dl for females.
• Anemia less than 10.5g/dl for any reason

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• Lee YH, Kim JH, Kim SR, Jin HY, Rhee EJ, Cho YM, Lee BW. Lobeglitazone, a Novel Thiazolidinedione, Improves Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes: Its Efficacy and Predictive Factors Related to Responsiveness. J Korean Med Sci. 2017 Jan;32(1):60-69. doi: 10.3346/jkms.2017.32.1.60.

  PMID: 27914133 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 6, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-01

Locations

KR (1)