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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Saroglitazar Group

Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks

Group Type ACTIVE_COMPARATOR

Saroglitazar

Intervention Type DRUG

Tab Saroglitazar 4 mg oral daily for 24 weeks

Pioglitazone Group

Tab Pioglitazone 30 mg daily fixed dose for 24 weeks

Group Type PLACEBO_COMPARATOR

Pioglitazone

Intervention Type DRUG

Tab Pioglitazone 30 mg oral daily for 24 weeks

Interventions

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Saroglitazar

Tab Saroglitazar 4 mg oral daily for 24 weeks

Intervention Type DRUG

Pioglitazone

Tab Pioglitazone 30 mg oral daily for 24 weeks

Intervention Type DRUG

Other Intervention Names

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Glitazar group Placebo Comparator group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No