| CTRI Number |
CTRI/2017/10/010306 [Registered on: 31/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/10/2017 |
| 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 in patients with type 2 diabetes mellitus |
|
Scientific Title of Study
|
To study the effect Of saroglitazar on insulin sensitivity in patients with type 2 diabetes mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nimisha Jain |
| Designation |
Senior resident |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department of Endocrinology
Post Graduate Institute of Medical Education and Research
Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9811724666 |
| Fax |
|
| Email |
nimishadr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nimisha Jain |
| Designation |
Senior resident |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department of Endocrinology
Post Graduate Institute of Medical Education and Research
Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9811724666 |
| Fax |
|
| Email |
nimishadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashu Rastogi |
| Designation |
Assistant Professsor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department of Endocrinology
Post Graduate Institute of Medical Education and Research
Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
ashuendo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Endocrinology,Post Graduate Institute of Medical Education and Research
Chandigarh, India |
| Zydus Research Center, Cadila Healthcare Ltd, Surkhej-bavla Highway (National Highway No.8 A), Moraiya, Ahmedabad 382213, Gujarat, India. Provided unrestricted drug and placebo. No role in trial design or conduct of study. |
|
|
Primary Sponsor
|
| Name |
Department of Endocrinology |
| Address |
Post Graduate Institute of Medical Education and Research
Chandigarh, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Nimisha Jain |
PGIMER |
Room No. 8,Department of Endocrinology, 4th floor, F- block, Nehru Hospital, Post Graduate Institute of Medical Education and Research
Sector 12
Chandigarh
CHANDIGARH |
0172-2756583
nimishadr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Identical placebo |
| Intervention |
Saroglitazar |
4 mg, orally, once a day for 4 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with T2DM between 30 and 60 years of age
2. Treatment naïve or on monotherapy with metformin/voglibose
3. Duration of Diabetes < 5 yr
4. GAD antibody negative status
5. HbA1c 7.0-9.0%
6. Serum triglyceride > 150mg/dL
7. BMI – 23-30 Kg/m2
|
|
| ExclusionCriteria |
| Details |
1. Type 1 diabetes mellitus or secondary diabetes
2. Past history of DKA or having ketonemia or ketonuria
3. Uncontrolled hypertension
4. Thyroid disorder
5. Renal dysfunction defined by eGFR < 60 ml/min/m2
6. Hepatic dysfunction (AST/ALT > 2.5 ULN, T.Bilirubin > 2 X ULN), myopathies
7. Receiving statins, fibrates, hormone replacement therapies and steroids
8. Seropositivity for HIV, HBV and HCV
9. Recent cardio vascular event (<6 months)
10. History of malignancy
11. Active infection
12. Alcohol ( >14 units/ week or 112 gm pure alcohol for men, > 7 units/week or 56 gm pure alcohol for women) (26) or drug abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the change in insulin sensitivity by hyperinsulinemic-euglycemic clamp in patients with T2DM and hypertriglyceridemia with saroglitazar as compared to placebo |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the change in body weight |
4 months |
| To assess the change in fasting lipids profile |
4 months |
| To assess the change in fasting C peptide |
4 months |
| To assess the change in fasting insulin |
4 months |
| To assess the change in fasting and post-prandial blood glucose and HbA1c |
4 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/04/2017 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
India is considered to be the “Diabetes Capital of the World†having 66 million subjects with diabetes and every fifth diabetic being an Indian. The morbidity and mortality in type 2 diabetes is attributed to microvascular and macrovascular complications. A plethora of therapeutic options are available including non pharmacological measures such as medical nutrition therapy (MNT) and exercise as well as pharmacological options such as sulfonylureas, metformin, thiazolidinediones, insulin, etc. It has been reported that insulin sensitisers are associated with reduction of cardiovascular diseases morbidity and mortality. PPAR-alpha agonists are approved for lipid control and PPAR-gamma agonist for achieving glycemic control in type 2 diabetes. Saroglitazar with dual PPAR alpha/gamma agonist activity, and excellent safety profile is being used for patients having diabetic dyslipidemia, as the drug has shown efficacy in improving both, the lipid due to PPAR-alpha agonistic property and the glycemic parameters , attributable to PPAR-gamma agonistic property. However, the drug is not yet approved for glycemic control in patients with Type 2 Diabetes Mellitus. Our aim is to assess the effect of saroglitazar on insulin sensitivity in patients of T2DM with hypertriglyceridemia. Our primary objective is to assess the change in insulin sensitivity by hyperinsulinemic-euglycemic clamp in patients with T2DM and hypertriglyceridemia with saroglitazar as compare to placebo. our primary hypothesis is that saroglitazar will cause an improvement in insulin sensitivity owing to its PPAR-gamma agonistic property. |