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

October 14, 2014 updated by: Hari Kumar, Command Hospital, India

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Panchkula, Haryana, India, 134107
        • Recruiting
        • Command Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saroglitazar Group
Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks
Drug: Saroglitazar
Tab Saroglitazar 4 mg oral daily for 24 weeks
Other Names:
  • Glitazar group
Placebo Comparator: Pioglitazone Group
Tab Pioglitazone 30 mg daily fixed dose for 24 weeks
Drug: Pioglitazone
Tab Pioglitazone 30 mg oral daily for 24 weeks
Other Names:
  • Placebo Comparator group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the NAFLD fibrosis score
Time Frame: At baseline and the end of 24 weeks
At baseline and the end of 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in body composition
Time Frame: At baseline and the end of 24 weeks
At baseline and the end of 24 weeks
Change in insulin resistance
Time Frame: At baseline and the end of 24 weeks
At baseline and the end of 24 weeks
Change in lipid profile
Time Frame: At baseline and the end of 24 weeks
At baseline and the end of 24 weeks
Change in HbA1c
Time Frame: At baseline and the end of 24 weeks
At baseline and the end of 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Command Hospital, India

Investigators

  • Principal Investigator: Hari Kumar, MD, Command Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

October 7, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO/2014/4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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