| CTRI Number |
CTRI/2025/08/092367 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Whether Saroglitazar can change arterial rigidity in patients with Diabetes and lipid abnormalities |
|
Scientific Title of Study
|
Effect of Saroglitazar on vascular stiffness in patients with Diabetic dyslipidemia: a Pilot
Randomized controlled trial |
| Trial Acronym |
Saroglitazar for Targeting Arterial Rigidity in Diabetes Mellitus (STAR-DM) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arindam Naskar |
| Designation |
Assistant Professor |
| Affiliation |
School of Tropical Medicine |
| Address |
Room No 16,
Department of Endocrinology, Nutrition and Metabolic diseases,
School of Tropical Medicine
108 CR Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arindam Naskar |
| Designation |
|
| Affiliation |
School of Tropical Medicine |
| Address |
Room No 16,
Department of Endocrinology, Nutrition and Metabolic diseases,School of Tropical Medicine
108 CR Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arindam Naskar |
| Designation |
Assistant Professor |
| Affiliation |
School of Tropical Medicine |
| Address |
Room No 16,Department of Endocrinology, Nutrition and Metabolic diseases, School of Tropical Medicine
108 CR Avenue
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ARINDAM NASKAR |
| Address |
Room No 16, School of Tropical Medicine, 108 CR Avenue, Kolkata 700073 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ARINDAM NASKAR |
School of Tropical Medicine |
Room No 16
Department of Endocrinology, Nutrition and Metabolic diseases
Kolkata
WEST BENGAL |
7044007741
indrani.bbs@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee |
Approved |
| Clinical Research Ethics Committee (CREC-STM), Calcutta School of Tropical Medicine, Chittaranjan Avenue, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab Saroglitazar 4 mg
|
Patients will receive Saroglitazar 4 mg daily orally for 6 months
|
| Comparator Agent |
Standard of care ( Statin therapy) |
Patient will receive standard of care ( maximum statin therapy to keep LDL at target) orally for 6 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult subjects (more than 18 years to less than 65 of age) of any gender
Established diagnosis of type 2 diabetes mellitus
Serum fasting triglyceride more than 150mg/dl
On Statin therapy for at least 6 month
Willing to providing written informed consent |
|
| ExclusionCriteria |
| Details |
Type 1 diabetes
Pregnancy or breastfeeding lady
Triglyceride level more than 500 mg/dL
Any concomitant thyroid disorders
Patients having estimated GFR less than 45 ml/min/1.73m2
Patients known Heart failure (Stage III or IV)
Severe liver dysfunction(Child Pugh C)
Baseline AST, ALT more than 3 times of upper limit
Hemoglobin less than 8 gm/dL
Tobacco abusers, Alcoholic and any kind of substance abusers
Patients with malignancy and/or on chemotherapy
Patients with infectious disease like HIV, Hepatitis B, Hepatitis C
• On other Triglyceride lowering therapy ( Fenofibrate, Icosapent Ethyl)
• Patients on oral contraceptive pills, antipsychotic drugs
• Patients taking steroids |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Saroglitazar vs standard of care on arterial stiffness in patients of T2DM and hyper
tryglyceridemia ( TG more than 150mg/dL) from baseline to week 24 |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare any changes from baseline to week 24 in
1. Lipid Profile
2. HbA1C,FBS,PPBS
3. BMI
4. eGFR
5. Urinary albumin creatinine ratio
6. ALT and AST |
6 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Saroglitazar is indicated for treatment of diabetic dyslipidemia ( mainly Hypertriglyceridemia) and Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD).Even though , this molecule is been available for more than one decade no study done has been done on its cardiovascular benefit. Through this study we would like to evaluate if Saroglitazar has any effect on vascular stiffness, which is one of the marker of atherosclerosis and further laying foundation for any future studies exploring the benefits of Saroglitazar. |