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CTRI Number  CTRI/2025/11/096864 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Diabetes Medication Use Among Patients with Diabetes and Heart Failure 
Scientific Title of Study   Prescription Pattern of Oral Antidiabetic Medications in Type II Diabetes Mellitus Patients with Heart Failure: A Retrospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Wilona Trinal D souza 
Designation  Student 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9380405406  
Fax    
Email  wtdsouza28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Roopa Satyanarayan Basutkar 
Designation  Assistant Professor G-III 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Roopa Satyanarayan Basutkar 
Designation  Assistant Professor G-III 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Source of Monetary or Material Support  
NITTE (Deemed to be University) Deralakatte, Mangalore, 575018 
 
Primary Sponsor  
Name  NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Sciences 
Address  Deralakatte, Mangalore, 575018 
Type of Sponsor  Other [Educational Institution] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrikrishna V Acharya  Justice K. S. Hegde Charitable Hospital, Deralakatte  Department of Endocrinology, Basement-Two, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA 		 9343967276

shrikrishnaacharya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Aged greater than 18 years
Patients with T2DM and HF
Patients administered on OHAs with/without insulin
At least one prescription for an oral diabetes medication
 
 
ExclusionCriteria 
Details  ESRD with dialysis
Patient with Type-1 Diabetes Mellitus
Death
Pregnant women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will investigate the annual rate of prescriptions of different therapeutic classes of oral antidiabetics in T2DM patients with Heart Failure  January 2019-August 2025 
 
Secondary Outcome  
Outcome  TimePoints 
This study will investigate the factors associated with the prescription of different therapeutic classes of oral antidiabetic drugs in T2DM patients with Heart Failure:
Age
Gender
BMI
Family history
Comorbidities – HTN, dyslipidemia, MI, Cardiac arrhythmias, previous history of CABG, CKD Stage I-IV and peripheral vascular disease.
DM and its complications
Social habits
Laboratory parameters (Glycemic parameters, lipid profile, renal function test and cardiac findings)

 		 January 2019-August 2025 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
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)   15/11/2025 
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="0"
Months="6"
Days="0" 
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 retrospective observational study aims to evaluate the prescribing patterns of oral antidiabetic medications among patients diagnosed with Type 2 Diabetes Mellitus and Heart Failure. The study will be conducted over a six-month period using data from inpatients recorded between January 2019 and August 2025, sourced from the Medical Records Department. The primary objective is to assess the utilization of different therapeutic classes of oral antidiabetics (e.g., Metformin, DPP-4 inhibitors, SGLT2 inhibitors, Sulfonylureas) in T2DM patients with Heart Failure and to analyze demographic and clinical factors influencing prescription trends. Data will be collected using a structured data collection form, and ethical clearance will be obtained prior to study commencement. Statistical analysis will involve descriptive methods using SPSS version 29.0. The study aims to identify adherence to evidence-based guidelines and uncover any inconsistencies in real-world prescribing practices. 
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