A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease

Fatty Liver Clinical Trial

— GLAZED  

Official title:

A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02265276
• Other study ID #: ENDO/2014/4
• Status: Recruiting
• Phase: Phase 3
• First received: October 7, 2014
• Last updated: October 14, 2014
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2014
• Source: Command Hospital, India
• Contact: Hari Kumar, MD
• Phone: 00918146141700
• Email: hariendo[@]rediffmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic syndrome. The prevalence of the same has been increasing rapidly in India, along with an increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and the therapeutic options are limited. Insulin sensitizing drugs are used in the management of NAFLD.

Description:

The therapeutic options for the management of nonalcoholic fatty liver disease (NAFLD) include lifestyle modifications, insulin sensitizers, vitamin E, antioxidants and cytoprotective agents. Glitazones are insulin sensitizing drugs and act by stimulating the PPAR gamma receptors. The drugs like Pioglitazone and Rosiglitazone have shown conflicting results in the NAFLD trials. Dual PPAR stimulators (PPAR gamma and PPAR alfa) are known as the "Glitazars" and are useful in simultaneously controlling the hyperglycemia, dyslipidemia and insulin resistance. Saroglitazar is the first drug approved in the investigators country for the management of diabetic dyslipidemia. The investigators plan to study the efficacy of this drug in comparison to Pioglitazone in patients of NAFLD over a period of 24 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Drug naive patients with NAFLD diagnosed on ultrasonography, BMI > 23 kg/m2 and ALT > 1.5 times the upper limit of normal

Exclusion Criteria:

• Use of any drugs other than lifestyle modification for NAFLD, HbA1c > 8% FBS>200, Bilirubin > 1.5 mg/dL

• Any illness likely to cause transaminitis and positive viral markers

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases

Intervention

Drug:
• Saroglitazar
Tab Saroglitazar 4 mg oral daily for 24 weeks
• Pioglitazone
Tab Pioglitazone 30 mg oral daily for 24 weeks

Locations

Country	Name	City	State
India	Command Hospital	Panchkula	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Command Hospital, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the NAFLD fibrosis score		At baseline and the end of 24 weeks	No
Secondary	Change in body composition		At baseline and the end of 24 weeks	No
Secondary	Change in insulin resistance		At baseline and the end of 24 weeks	No
Secondary	Change in lipid profile		At baseline and the end of 24 weeks	No
Secondary	Change in HbA1c		At baseline and the end of 24 weeks	No