Fatty LiverPhase 3GLAZEDNCT02265276
A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease
A Phase 3 study testing Saroglitazar and Pioglitazone in people with Fatty Liver, run by Command Hospital, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Saroglitazar and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2014to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Drug naive patients with NAFLD diagnosed on ultrasonography, BMI > 23 kg/m2 and ALT > 1.5 times the upper limit of normal
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Command Hospital
Panchkula, Haryana, 134107
JBS Yadava, 00911722867534, hariendo@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatty Liver
- Being tested
- Saroglitazar, Pioglitazone
- Keywords
- NAFLD, Diabetes, Glitazone
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaroglitazarDrug
Also called Glitazar group
Tab Saroglitazar 4 mg oral daily for 24 weeks
PioglitazoneDrug
Also called Placebo Comparator group
Tab Pioglitazone 30 mg oral daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Saroglitazar Group | Active comparator | Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks Receives: Drug: Saroglitazar |
| Pioglitazone Group | Placebo comparator | Tab Pioglitazone 30 mg daily fixed dose for 24 weeks Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the NAFLD fibrosis score
Measured: At baseline and the end of 24 weeks
Secondary outcomes (4)
Change in body composition
Measured: At baseline and the end of 24 weeks
Change in insulin resistance
Measured: At baseline and the end of 24 weeks
Change in lipid profile
Measured: At baseline and the end of 24 weeks
Change in HbA1c
Measured: At baseline and the end of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Command Hospital, India
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hari Kumar, Command Hospital, India
- Investigators
- Hari Kumar, MD, Principal investigator, Command Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265276
- Sponsor's protocol ID
- ENDO/2014/4
- Acronym
- GLAZED
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED Trial)
- ClinicalTrials.gov ID
- NCT02265276
- Acronym / sponsor ID
- GLAZED / ENDO/2014/4
- Conditions
- Fatty Liver
- Keywords
- NAFLD, Diabetes, Glitazone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Command Hospital, IndiaOther government
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saroglitazar Group | Active comparator | Drug: SaroglitazarTab Saroglitazar 4 mg oral daily fixed dose for 24 weeks |
| Pioglitazone Group | Placebo comparator | Drug: PioglitazoneTab Pioglitazone 30 mg daily fixed dose for 24 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Drug naive patients with NAFLD diagnosed on ultrasonography, BMI > 23 kg/m2 and ALT > 1.5 times the upper limit of normal
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaroglitazarAlso: Glitazar groupTab Saroglitazar 4 mg oral daily for 24 weeks | Drug | Saroglitazar Group |
| PioglitazoneAlso: Placebo Comparator groupTab Pioglitazone 30 mg oral daily for 24 weeks | Drug | Pioglitazone Group |
Primary outcome
Change in the NAFLD fibrosis score
Time frame: At baseline and the end of 24 weeks
4 secondary outcomes
Change in body composition
Time frame: At baseline and the end of 24 weeks
Change in insulin resistance
Time frame: At baseline and the end of 24 weeks
Change in lipid profile
Time frame: At baseline and the end of 24 weeks
Change in HbA1c
Time frame: At baseline and the end of 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hari Kumar, MD principal investigator
Command Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saroglitazar and Pioglitazone in people with Fatty Liver, run by Command Hospital, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hari Kumar, MD (00918146141700, hariendo@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the NAFLD fibrosis score (time frame: At baseline and the end of 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.