| CTRI Number |
CTRI/2024/11/076537 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
EFFECT OF BEMPEDOIC ACID AND EZETIMIBE ON BLOOD SUGAR LEVEL IN PATIENTS WITH BOTH DIABETES AND HIGH CHOLESTEROL |
|
Scientific Title of Study
|
Effectiveness Of Bempedoic Acid -Ezetimibe Fixed Dose Combination On Insulin Sensitivity In Diabetic Dyslipidemic Patients - A Prospective, Open-label, Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J S Kumar |
| Designation |
MBBS., MD., FRCP., Professor and HOD of General Medicine |
| Affiliation |
SRM Institute |
| Address |
Department of General Medicine, Unit- 1 and 7, Block-B, Room Number G-04, Diabetic OPD, SRM Hospital and Research Centre, SRM Nagar, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840047678 |
| Fax |
|
| Email |
kumarj1@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V M Vijay kumar |
| Designation |
M.PHARM., Ph.D., Professor and HOD of Pharmacy Practice |
| Affiliation |
SRM Institute |
| Address |
Department of Pharmacy Practice,J-4 Block, Room Number- 02, SRM Hospital and Research Centre, SRM Nagar, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
vijaypractice@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthick Perumal |
| Designation |
Doctor of Pharmacy |
| Affiliation |
SRM Institute |
| Address |
Department of Pharmacy Practice, J-Block, Room Number- 04, SRM Hospital and Research Centre, SRM Nagar, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6383450839 |
| Fax |
|
| Email |
kp1366@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Pharmacy
SRM Medical College Hospital and Research Centre, Kattankulathur- 603 203,Chennai,Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
SRM College of Pharmacy |
| Address |
SRM Medical College Hospital and Research Centre,
Kattankulathur,Chennai |
| 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 |
| Karthick Perumal |
SRM Hospital and Research Centre |
Department of General Medicine, Unit- 1 and 7, Block-B, Room Number G-04, Diabetic OPD, SRM Hospital and Research Centre, SRM Nagar, Kattankulathur- 603203, Chennai, India
Kancheepuram
TAMIL NADU |
6383450839
kp1366@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E789||Disorder of lipoprotein metabolism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group- Existing baseline statin therapy. |
Existing statin therapy for the period of 90 days. |
| Intervention |
Test Group 1, Bempedoicacid 180mg plus Ezetimibe 10mg as a fixed dose combination.
|
Bempedoicacid 180mg plus Ezetimibe 10mg as a fixed dose combination over baseline statin therapy, given through oral route, once daily at night time for the period of 90 days |
| Intervention |
Test Group 2, Ezetimibe 10mg over existing baseline statin therapy. |
Ezetimibe 10mg over existing baseline statin therapy, given through oral route, once daily at night time for the period of 90 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Men and women above 18 years of age are include.
2. Patients diagnosed with Type 2 Diabetes Mellitus and dyslipidemia.
3. Participants receiving baseline statin therapy should have fasting LDL-C level of 100mg/dL or higher at first screening visit.
4. Patients receiving antihyperglycemic medication before randomization and HbA1c between 6.5% to 10% at randomization
|
|
| ExclusionCriteria |
| Details |
1. Patients with recent history of clinically significant cardiovascular disease, including uncontrolled hypertension, planned revascularization procedure, NYHA class IV heart failure.
2. Myocardial infarction, severe or unstable angina, coronary angioplasty, coronary artery bypass graft surgery, stroke, transient ischaemic attack within 3 months of screening are excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the insulin sensitivity using HOMA IR index score and improvement of beta cell function C peptide. |
After 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the reduction in HbA1c levels and reducing LDL-C and total cholesterol levels in diabetic dyslipidemic patients. |
After 90 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/11/2024 |
| 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="0"
Months="6"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, open label, prospective study which involves patients above 18 years of age who are diagnosed with Type 2 Diabetes Mellitus and dyslipidemia. Participants receiving baseline statin therapy should have fasting LDL-C level of 100mg/dL or higher at first screening visit.
Patients are randomized into 3 groups based on Random allocation software version 2.0
Initial Evaluations: VISIT-0 (Day-1) Fasting Blood Glucose Fasting Insulin Fasting Low Density Lipoprotein Fasting Total Cholesterol HbA1c Postprandial Blood Glucose Fasting C- Peptide Fasting Triglycerides HOMA-IR index score online calculator KIER Scoring Scale Group 1 (Test group 1): Involves 30 patients administered with Bempedoic acid(180mg) + Ezetimibe(10mg) as a fixed dose combination over baseline statin therapy for 90 days (Once daily) at bedtime. Group 2 (Test group 2): Involves 30 patients administered with Ezetimibe(10mg) as a monotherapy over baseline statin therapy for 90 days (Once daily) at bedtime. Group 3 (Control group): Involves 30 patients continuing existing statin therapy. Patients are contacted through telephone regarding medication adherence on visit 1 (Day-30) and visit 2 (Day-60). Patients are requested for In-person visit 3 (Day 90) for the follow up with above mentioned parameters. The results are statistically compared and reported after 90 days of treatment.
|