| CTRI Number |
CTRI/2025/07/090135 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In comparison to pioglitazone does lobeglitazone affect the hardening of arteries in diabetic patients |
|
Scientific Title of Study
|
Effect of Lobeglitazone on arterial stiffness in comparison to pioglitazone in patients with type 2 diabetes : a pilot randomized controlled trial |
| Trial Acronym |
LOPAS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arindam Naskar |
| Designation |
|
| Affiliation |
School of Tropical Medicine |
| Address |
Room no 16, School of Tropical Medicine, 108 CR Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arindam Naskar |
| Designation |
|
| Affiliation |
School of Tropical Medicine |
| Address |
Room no 16, School of Tropical Medicine, 108 CR Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arindam Naskar |
| Designation |
|
| Affiliation |
School of Tropical Medicine |
| Address |
Room no 16, School of Tropical Medicine, 108 CR Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Arindam Naskar |
| Address |
Room No 16, School of Tropical Medicine, 108 CR Avenue, Kolkata, West Bengal, Pin 700073 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Arindam Naskar |
School of Tropical Medicine |
Room no 16, Department of Endocrine, Nutrition and Metabolic Diseases, 108 CR Avenue
Kolkata
WEST BENGAL |
7044007741
indrani.bbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee |
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 |
| Intervention |
Lobeglitazone |
patients will receive lobeglitazone 0.5mg per day |
| Comparator Agent |
Pioglitazone |
Patients will receive pioglitazone 15 to 30mg per day |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes mellitus with HbA1c between 7 to 9
Willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Pregnancy or breast feeding
Patient with eGFR less than 45 mL/min
Patients with cardiac rhythm disorders or heart failure
Baseline AST and ALT more than 3 times of upper limit
Patient with BMI more than 40
Patient with hemoglobin less than 8g/dL
History of any spine fractures
Patients with malignancies
Patients on insulin, SGLT 2i and GLP 1 agonist therapy
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of lobeglitazone vs pioglitazone on arterial stiffness as an add on therapy to preexisting anti diabetic drugs in patients with type 2 diabetes |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HbA1c, fasting blood sugar, post prandial blood sugar |
6 months |
| Proportion of patients acheiving HbA1c less than 7 percentage |
6 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
01/08/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Vascular stiffness measured by Pulse Wave Velocity is a marker of atherosclerosis. Diabetes mellitus is a risk factor form developing atherosclerosis and relater complication. Studies have show that pioglitazone which belongs to a class of drugs called thiozolidinedione, can improve glycemic control and reduces risk of major adverse cardiovascular events. Lobeglitazone which is a drug belonging to the same class as pioglitazone was launched in 2022 in India. Studies have showed that lobeglitazone can improve glycemic control. A few preclinical trials have shown that lobeglitazone can improve vascular stiffness. Our study aims to fill this knowledge gap of wheather Lobeglitazone can reduce arterial stiffness as compared to pioglitazone. Methodolgy A total of 46 diabetic patients will be randomized into two groups. The intervention arm will receive lobeglitazone and the compartator arm will receive pioglitazone. Vascular stiffness will be measured at baseline and after 6 months of therapy and the changes will be analysed.
|