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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University

Criteria

Inclusion Criteria:

1. Type Ⅱ diabetes mellitus

2. Non-alcoholic fatty liver disease: subjects who have CAP(Controlled Attenuation Parameter) ≥ 250dB/m measured by transient elastography (fibroscan) at screening test

3. Age ≥ 20 years

4. 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

5. Agreement with written informed consent

Exclusion Criteria:

1. Patients whose alcohol consumption >210g/week for males and 140g/week for females

2. chronic B viral hepatitis, chronic C viral hepatitis, Type I diabetes, or secondary diabetes

3. having a history of acute or chronic metabolic acidosis including diabetic ketoacidosis

4. patients who have been taking other oral hypoglycemic agents except metformin or insulin within recent 8 weeks

5. who experienced hypersensitivity reaction against metformin or glitazone drugs

6. who has been treated with corticosteroids for at least 14 days within 2 month prior to Screening

7. having a history of lactic acidosis

8. having genetic predispositions such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

9. who are in condition of malnutrition, starvation, cachexia, severe infection, major trauma, hypopituitarism, or adrenal insufficiency

10. diagnosed with cancer within 2 years or having chemo or radiotherapy for cancer treatment

11. a history of drug abuse or chronic alcoholism

12. a history of heart failure (NYHA class III and IV) or uncontrolled arrhythmia

13. 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)

14. Renal dysfunction: Serum creatinine greater than 1.5mg/dl for males and 1.4mg/dl for females.

15. Anemia less than 10.5g/dl for any reason

16. Pregnant women or nursing mothers

17. Fertile women who not practice contraception with appropriate methods

18. in treatment concomitant drug from other clinical trials within 4 weeks from enrollment

19. who did not agree with written informed consent