| 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
|
|
|
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
|
|
|
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
|
|
|
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. |