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CTRI Number  CTRI/2020/06/025946 [Registered on: 17/06/2020] Trial Registered Prospectively
Last Modified On: 03/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of saroglitazar on vascular function in patients with type 2 diabetes 
Scientific Title of Study   "Efficacy and safety of saroglitazar on vascular function in patients with type 2 diabetes mellitus: A randomized, double blind, parallel arm, placebo controlled trial" 
Trial Acronym  STARDDOM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akila S 
Designation  Senior Resident, Dept. of Clinical Pharmacology 
Affiliation  JIPMER 
Address  Department of Clinical Pharmacology, Third Floor, Institute Block, JIPMER, Pondicherry-605006

Pondicherry
PONDICHERRY
605006
India 
Phone  7598431192  
Fax    
Email  akilasrinivas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Sandhiya 
Designation  Associate Professor,Dept. of Clinical Pharmacology 
Affiliation  JIPMER 
Address  Department of Clinical Pharmacology, Third Floor, Institute Block, JIPMER, Pondicherry-605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9443492922  
Fax    
Email  sandhiyaselvarajan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sadishkumar Kamalanathan C 
Designation  Additional Professor, Dept. of Endocrinology 
Affiliation  JIPMER 
Address  Department of Endocrinology Fourth Floor, Super Speciality Block, JIPMER, Puducherry-605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9629528518  
Fax    
Email  sadishkk@gmail.com  
 
Source of Monetary or Material Support  
JIPMER, Puducherry 
 
Primary Sponsor  
Name  JIPMER Intramural Research Grant 
Address  JIPMER, Dhanvantri Nagar, Gorimedu, Pondicherry-605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akila S  JIPMER Hospital  Dept. of Clinical Pharmacology,Third Floor, Institute Block, JIPMER, Pondicherry-605006
Pondicherry
PONDICHERRY 
7598431192

akilasrinivas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institutional Ethics Committee for Interventional studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Placebo   Oral similar looking Placebo once daily for 3 months in addition to standard background therapy (Metformin with or without sulfonylureas) 
Intervention  Saroglitazar   Oral Saroglitazar 4 mg once daily for 3 months with standard background therapy (Metformin with or without sulfonylureas) 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with type 2 diabetes mellitus diagnosed by American Diabetes Association (ADA) criteria within the past 3 months to 10 years, on stable dose of metformin with or without sulfonylureas, for at least past 2 months, with HbA1C of 7.5-9% 
 
ExclusionCriteria 
Details  1) Liver dysfunction (AST,ALT > 2 times the upper limit of normal)
2) Renal dysfunction (GFR <60 ml/min/1.73 m2)
3) Patient with concurrent illnesses like CAD(Coronary Artery Disease), CVA( cerebrovascular accidents), PVD(Peripheral Vascular Disease), CKD( Chronic Kidney Disease)other than hypertension
4) Patients taking anti diabetic drugs other than metformin and sulfonylureas
5) Pregnant women or lactating mothers; women in reproductive age group not practicing contraceptive measures.
6) Patients who had participated in other trials in the past three months.
7) Patients with active infections such as diabetic foot infection etc 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Carotid femoral pulse wave velocity  Carotid femoral pulse wave velocity at baseline, 1st, 2nd, and 3rd months 
 
Secondary Outcome  
Outcome  TimePoints 
1. s-ICAM, S-VCAM, E-selectin, interleukin-6
2.Lipid profile
3. Adverse drug reactions to saroglitazar 
1. s-ICAM, S-VCAM, E-selectin, interleukin-6 at baseline and 3 months
2.Lipid profile at baseline and 3 months
3. Adverse drug reactions to saroglitazar at baseline, 1st, 2nd, 3rd months 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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   N/A 
Date of First Enrollment (India)   07/07/2020 
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="2"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The Institute Ethics Committee approval will be obtained. CTRI Registration will be done. Eligible patients will be included and written informed consent will be taken. Following brief history taking and physical examination, the patients will be randomized to receive either tablet Saroglitazar 4 mg od or similar looking placebo as add on therapy for 3 months in addition to the standard background treatment of metformin and sulfonylureas. Carotid femoral (aortic) pulse wave velocity and other parameters of vascular functions will be measured at baseline and every month during follow up visits for a period of 3 months. 7 ml of venous blood will be taken under sterile precautions to assess fasting and postprandial blood glucose, lipid profile, liver and renal function tests and markers of endothelial function namely ICAM, VCAM, E-selectin, IL-6, at baseline and after 3 months of study period.4 ml of venous blood will be taken at first and second months to measure fasting plasma glucose and postprandial blood glucose, Liver and Renal Function Test. During every month follow up visits, the patients will be enquired about adherence and adverse drug reactions to saroglitazar. Change in anti diabetic medications, if any, will be recorded during all three follow up visits. Blood glucose monitoring (Fasting and postprandial blood glucose) will be done every month for the period of 3 months for clinical management of participants. Type 2 diabetes patients who have dyslipidemia (Cholesterol > 200 mg/dL and triglycerides > 150 mg/dl) will be started with statins, irrespective of the intervention group to which they are randomized.

 
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