| CTRI Number |
CTRI/2024/05/067860 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
Adverse drug reaction of SGLT2 inhibitors |
|
Scientific Title of Study
|
Real-world safety assessment of SGLT2 inhibitors: an observational study in diverse patient population |
| 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 Likhith Prasanna |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of pharmacology,
Kasturba Medical College,
Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922365 |
| Fax |
|
| Email |
likhith.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Kumari K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Pharmacology,
Kasturba Medical College,
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922365 |
| Fax |
|
| Email |
meena.kumari@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meena Kumari K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Pharmacology,
Kasturba Medical College,
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922365 |
| Fax |
|
| Email |
meena.kumari@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Madhav Nagar, Manipal, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Likhith Prasanna |
Kasturba Hospital, Manipal |
Department of Endocrinology OPD,
Room no: 37,Department of Cardiology.
Udupi
KARNATAKA |
08202922365
likhith.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital - IEC-2 (Student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I240||Acute coronary thrombosis not resulting in myocardial infarction, (2) ICD-10 Condition: N18||Chronic kidney disease (CKD), (3) ICD-10 Condition: E08||Diabetes mellitus due to underlying condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged ≥18 years newly initiated on SGLT2 inhibitors as per standard protocol. |
|
| ExclusionCriteria |
| Details |
1.Those patients who are already on SGLT2 inhibitors
2.Patients on cancer chemotherapy, retroviral drugs and glucocorticoids
3.Pregnant females and lactating mothers
4.Patients refusing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate serious and non-serious adverse effects of SGLT2 inhibitors in diabetic and non-diabetic population |
6months,1year,1.5years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze the usage of SGLT2 inhibitors as per prescription in diabetic & non-diabetic population |
6months,1year,1.5years. |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
Final Enrollment numbers achieved (Total)= "192"
Final Enrollment numbers achieved (India)="192" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
06/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/03/2026 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Objectives of the study: · To evaluate serious and non-serious adverse effects of SGLT2 inhibitors in diabetic and non-diabetic population. · To analyze the usage of SGLT2 inhibitors as per prescription in diabetic and non-diabetic population. This is a Prospective longitudinal study that has been obtained approval from the Institutional Ethics Committee(IEC) and study will commence after clearance from the Clinical Trials Registry of India (CTRI). The inclusion criteria includes patients initiating medication with Sodium-Glucose Co-Transporter-2 inhibitors (SGLT2i). Both inpatients and outpatients from Cardiology and Endocrinology departments will be recruited after obtaining a written informed consent and observed for a minimum of 6 months if any potential adverse drug reactions occurs based on the proforma and assessment scales such as Naranjo’s scale, Hartwig’s severity assessment scale and Modified Schumock & Thornton scale within a diverse and comprehensive patient population on SGLT2 inhibitors. The Naranjo Adverse Drug Reaction Probability Scale is a tool used to assess the likelihood that a particular adverse reaction in a patient is actually caused by a medication they are taking. Each question is scored, and the total score is used to categorize the likelihood of the adverse reaction being caused by the medication as definite, probable, possible, or doubtful. Hartwig’s severity assessment scale will be used to assess severity of ADRs. It classifies ADRs into mild, moderate & severe groups. The Schumock and Thornton Scale, also known as the Preventability Scale, is a tool used to assess the preventability of adverse drug events (ADEs). These scales will be administered if the patient developed any ADRs. Permission to usage of these scales has been obtained. |