| CTRI Number |
CTRI/2016/03/006778 [Registered on: 31/03/2016] Trial Registered Retrospectively |
| Last Modified On: |
30/03/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The role of saroglitazar in the treatment of prediabetes and elevated lipid levels |
|
Scientific Title of Study
|
Study of saroglitazar in treatment of prediabetes with dyslipidemia |
| Trial Acronym |
STOP-D |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Bhosle |
| Designation |
Consultant Diabetologist, Deogiri Diabetes Centre |
| Affiliation |
Deogiri Diabetes Centre |
| Address |
Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7770087870 |
| Fax |
|
| Email |
drdeepakbhosle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Bhosle |
| Designation |
Consultant Diabetologist, Deogiri Diabetes Centre |
| Affiliation |
Deogiri Diabetes Centre |
| Address |
Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7770087870 |
| Fax |
|
| Email |
drdeepakbhosle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Bhosle |
| Designation |
Consultant Diabetologist, Deogiri Diabetes Centre |
| Affiliation |
Deogiri Diabetes Centre |
| Address |
Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7770087870 |
| Fax |
|
| Email |
drdeepakbhosle@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Deogiri Diabetes Centre |
| Address |
46, Samta Nagar, Kranti Chowk Police station Road, Aurangabac 431001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Deepak Bhosle |
Deogiri Diabetes Centrer |
Deogiri Diabetes Centrer, Aurangabad
Aurangabad
MAHARASHTRA |
7770087870
drdeepakbhosle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-ECRHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Prediabetes with dyslipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Saroglitazar |
4 mg; Route - oral; Tabletl once daily; for 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in the study and follow protocol.
Patients of either sex with age group of 20-60 years.
Prediabetic patients with HbA1c 5.7- 6.5 % and deranged lipids as per NCEP guidelines.
|
|
| ExclusionCriteria |
| Details |
Type 1 diabetes mellitus
Type 2 diabetes
Secondary hypertension.
Bronchial asthma.
Chronic obstructive pulmonary disease.
Any other respiratory disorders.
g. Any Hepatic or renal diseases.
h. Any other cardiovascular disorder.
 Pregnant and lactating women.
 History of known allergy to drugs.
 Patient concurrently taking other medication which is known to affect the blood sugar and lipid parameters.
 Smoker, alcoholic and tobacco chewer.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in serum triglycerides |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in HbA1c, total cholesterol, LDL-C, VLDL-C, non HDL-C, HDL-C |
week 24 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/04/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The preclinical and clinical studies of saroglitazar have suggested that saroglitazar is a potent triglyceride lowering agent along with significant improvement in insulin sensitivity. In various studies, saroglitazar has been found safe and well tolerated. The current study is designed to evaluate the effect of saroglitazar 4mg once daily in patients with prediabetes and dyslipidemia. This is an observational, single centre study. Subjects will be followed up for 24 weeks duration. Lipid (total cholesterol, triglycerides, VLDL-C, LDL-C, HDL-C and non HDL-C) and glycemic parameters (HbA1c) will be evaluated at baseline and at 24 weeks follo-up. Kidney and liver functions and ECG will also be done to evaluate the safety of saroglitazar. |