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

Primary Purpose

Fatty Liver

Status

Unknown status

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Saroglitazar

Pioglitazone

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring NAFLD, Diabetes, Glitazone

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Command HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Saroglitazar Group

Pioglitazone Group

Arm Description

Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks

Tab Pioglitazone 30 mg daily fixed dose for 24 weeks

Outcomes

Primary Outcome Measures

Change in the NAFLD fibrosis score

Secondary Outcome Measures

Change in body composition

Change in insulin resistance

Change in lipid profile

Change in HbA1c

Full Information

NCT ID

NCT02265276

First Posted

October 7, 2014

Last Updated

October 14, 2014

Sponsor

Command Hospital, India

1. Study Identification

Unique Protocol Identification Number

NCT02265276

Brief Title

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

Acronym

GLAZED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Command Hospital, India

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatty Liver

Keywords

NAFLD, Diabetes, Glitazone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Saroglitazar Group

Arm Type

Active Comparator

Arm Description

Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks

Arm Title

Pioglitazone Group

Arm Type

Placebo Comparator

Arm Description

Tab Pioglitazone 30 mg daily fixed dose for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Saroglitazar

Other Intervention Name(s)

Glitazar group

Intervention Description

Tab Saroglitazar 4 mg oral daily for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Pioglitazone

Other Intervention Name(s)

Placebo Comparator group

Intervention Description

Tab Pioglitazone 30 mg oral daily for 24 weeks

Primary Outcome Measure Information:

Title

Change in the NAFLD fibrosis score

Time Frame