| CTRI Number |
CTRI/2014/10/005131 [Registered on: 22/10/2014] Trial Registered Retrospectively |
| Last Modified On: |
17/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study is conducted to compare the effectiveness and safety of saroglitazar and metformin combination therapy to that of fenofibrate and metformin combination therapy in Indian patients with type 2 diabetes mellitus and increased plasma triglyceride level |
|
Scientific Title of Study
|
Comparison of effectiveness and safety of add on therapy of saroglitazar and fenofibrate with metformin in Indian patients with type 2 diabetes mellitus and predominant hypertriglyceridemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arijit Ghosh |
| Designation |
Assistant Professor |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
Dept of Pharmacology
NRS Medical College
Kolkata
WEST BENGAL
700014
India |
| Phone |
919874727137 |
| Fax |
|
| Email |
drarijitghosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arijit Ghosh |
| Designation |
Assistant Prof |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
Dept of Pharmacology
NRS Medical College
Kolkata
WEST BENGAL
700014
India |
| Phone |
919874727137 |
| Fax |
|
| Email |
drarijitghosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arijit Ghosh |
| Designation |
Assistant Prof |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
Dept of Pharmacology
NRS Medical College
Kolkata
WEST BENGAL
700014
India |
| Phone |
919874727137 |
| Fax |
|
| Email |
drarijitghosh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pranab Kumar Sahana |
| Address |
Dept of Endocrinology
NRS Medical College
Kolkata-700014 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Arijit Ghosh |
Dept of Pharmacology
NRS Medical College
Kolkata-700014 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arijit Ghosh |
Out Patient Department |
Dept of Endocrinology
NRS Medical College
Kolkata-700014
Kolkata
WEST BENGAL |
919874727137
drarijitghosh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nilratan Sircar Medical College IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Indian patients with type 2 diabetes mellitus and predominant hypertriglyceridemia, (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fenofibrate and metformin |
Metformin (1000 mg/day) + Fenofibrate (160 mg/day) for 12 weeks |
| Intervention |
Saroglitazar and metformin |
Metformin (1000 mg/day) + Saroglitazar (4 mg/day) for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Newly diagnosed cases of type 2 diabetes mellitus with predominant hypertriglyceridemia
2.Plasma triglyceride level ≥ 150 mg/dl
3.HbA1C ≥ 6.5 & ≤ 8
|
|
| ExclusionCriteria |
| Details |
1Female patients who are pregnant or lactating
2.Patients on any oral anti-diabetic drug
3.FPG > 250mg/dl, PPPG > 350mg/dl, LDL-C > 130 mg/dl
4.Co-morbid cardiovascular, renal and psychiatric diseases
5.Co-administration of drugs that are likely to interact with saroglitazar, fenofibrate or metformin and drugs that are likely to alter lipid profile and glycemic status
6.Past history of cardiovascular disease
7.Patients with rising FPG and PPPG levels at week 4 or 8.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in TG |
At week 12 visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in TC, HDL, LDL, HbA1C, FPG & PPPG |
At week 12 |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/07/2014 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Diabetes have increased cardiovascular risk. The risk is exaggerated by dyslipidemia. Saroglitazar is the first dual PPAR alfa/gamma agonist for patients suffering from diabetic dyslipidemia.
Present study is designed to compare the effectiveness and safety of add on therapy of saroglitazar and fenofibrate with metformin in Indian patients with diabetic dyslipidemia. |