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

Sponsor
Command Hospital, India (Other)
Overall Status
Unknown status
CT.gov ID
NCT02265276
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
11
Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED Trial)
Study Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2015
Anticipated Study Completion Date :
Sep 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in the NAFLD fibrosis score [At baseline and the end of 24 weeks]

    Secondary Outcome Measures

    1. Change in body composition [At baseline and the end of 24 weeks]

    2. Change in insulin resistance [At baseline and the end of 24 weeks]

    3. Change in lipid profile [At baseline and the end of 24 weeks]

    4. Change in HbA1c [At baseline and the end of 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Command Hospital Panchkula Haryana India 134107

    Sponsors and Collaborators

    • Command Hospital, India

    Investigators

    • Principal Investigator: Hari Kumar, MD, Command Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hari Kumar, Endocrinologist, Command Hospital, India
    ClinicalTrials.gov Identifier:
    NCT02265276
    Other Study ID Numbers:
    • ENDO/2014/4
    First Posted:
    Oct 15, 2014
    Last Update Posted:
    Oct 16, 2014
    Last Verified:
    Oct 1, 2014
    Keywords provided by Hari Kumar, Endocrinologist, Command Hospital, India
    NAFLD, Diabetes, Glitazone
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Pioglitazone

    Study Results

    No Results Posted as of Oct 16, 2014