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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02265276
Other study ID # ENDO/2014/4
Secondary ID
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


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
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