| CTRI Number |
CTRI/2026/04/107639 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
KAP Survey |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Clinical Benefits of Gliclazide in Type 2 Diabetes: An Indian KAP Study |
|
Scientific Title of Study
|
LEveraging Insights on the Clinical Relevance of GliclAzide for GluCo-Centric & BeYond
Benefits in T2DM Care Continuum: An Indian KAP Study (LEGACY-INDIA) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MC/GCZ/26-001 Version 1.0 Dated 13 Jan 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Visakh R |
| Designation |
Principal investigator |
| Affiliation |
Dr. Reddys Laboratories Ltd. |
| Address |
Dr. Reddys Laboratories Ltd.
8-2-337, Road No. 3
Banjara Hills, Hyderabad
Telangana – 500034, India
Hyderabad
TELANGANA
500034
India |
| Phone |
9995151539 |
| Fax |
|
| Email |
visakhr@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Mujtaba Hussain Naqvi |
| Designation |
Head Clinical research |
| Affiliation |
Dr. Reddys Laboratories Ltd. |
| Address |
Medical Affairs Department, Global Generics India Division, 8-2-337, Road No. 3, Banjara Hills, Hyderabad, TELANGANA, 500034, India
Hyderabad
TELANGANA
500034
India |
| Phone |
7032969523 |
| Fax |
|
| Email |
mujtabanaqvi@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syed Mujtaba Hussain Naqvi |
| Designation |
Head Clinical research |
| Affiliation |
Dr. Reddys Laboratories Ltd. |
| Address |
Medical Affairs Department, Global Generics India Division, 8-2-337, Road No. 3, Banjara Hills, Hyderabad, TELANGANA, 500034, India
Hyderabad
TELANGANA
500034
India |
| Phone |
7032969523 |
| Fax |
|
| Email |
mujtabanaqvi@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr. Reddys Laboratories Ltd.
8-2-337, Road No. 3
Banjara Hills, Hyderabad
Telangana – 500034, India |
|
|
Primary Sponsor
|
| Name |
Dr. Reddys Laboratories Ltd. |
| Address |
Dr. Reddys Laboratories Ltd.
8-2-337, Road No. 3
Banjara Hills, Hyderabad
Telangana – 500034, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Visakh R |
Dr. Reddys Laboratories Ltd. |
Dr. Reddys Laboratories Ltd.
8-2-337, Road No. 3
Banjara Hills, Hyderabad
Telangana – 500034, India
Hyderabad
TELANGANA |
9995151539
visakhr@drreddys.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Shubhdisha Business Solutions |
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 |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Endocrinologists, diabetologists, consultant physicians, healthcare professionals practicing at healthcare setups ,clinics ,hospitals located across various regions of India |
|
| ExclusionCriteria |
| Details |
1. Healthcare professionals unwilling to participate in the KAP study
2. Healthcare professionals not treating patients with diabetes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To understand the knowledge, attitude, and practice, KAP, patterns of Indian clinicians regarding the clinical importance and relevance of gliclazide (in glucose control and microvascular complications)
2. To seek practical insights regarding gliclazide application in the real-world Indian T2DM clinical care continuum. |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
15/04/2026 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 prospective, observational, KAP survey will begin after Ethics Committee (IEC) approval. Approximately, 250 healthcare professionals will be randomly invited to participate and will provide written informed consent. A 20 to 25 item quesstionnaire, validated by expert clinicians, will be administered via Google Forms, paper format, or interviews. Responses will be analyzed to assess clinicians’ knowledge, attitudes, and practices regarding the clinical relevance of gliclazide in glucose control and microvascular complications. The survey will take up to 1.5 hours, and all data will remain confidential and anonymized |