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CTRI Number  CTRI/2024/07/071065 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Antidiabetic medications prescribing pattern in patients with Myocardial infraction 
Scientific Title of Study   Prescription Pattern Of Antidiabetic Medications In Type II Diabetes Mellitus Patients With Acute Myocardial Infraction: 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  Smera K P 
Designation  M . Pharm Student  
Affiliation  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice NGSM institute of Pharmaceutical sciences, Paneer, Deralakatkte, Mangalaru Dakshina Kannada KARNATAKA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7025517396  
Fax    
Email  smerasunil1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Roopa BS 
Designation  Assistant Professor Grade III 
Affiliation  NGSM institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice NGSM institute of Pharmaceutical sciences , Paneer, Deralakatkte, Mangalaru Dakshina Kannada karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Roopa BS 
Designation  Assistant Professor Grade III 
Affiliation  NGSM institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice NGSM institute of Pharmaceutical sciences , Paneer, Deralakatkte, Mangalaru Dakshina Kannada karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Source of Monetary or Material Support  
Justice K S Hegde Charitable Hospital,Deralakatte Mangalore,575018 
 
Primary Sponsor  
Name  Justice K S Hegde Charitable Hospital Mangalore 
Address  Deralakatte, Mangalore,575018 
Type of Sponsor  Private hospital/clinic 
 
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 Roopa B S  Justice KS Hegde charitable hospital  Department of Endocrinology Justice K S Hegde Charitable Hospital Deralakatte Mangaluru 575018
Dakshina Kannada
KARNATAKA 		 9047155003

roopa.satyanarayan@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences - Institutional Ethics Committee   Approved 
NGSM Institute Of Pharmaceutical Sciences Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  T2DM patients of either gender aged 18 years and above with at least one cardiovascular coexisting condition 
 
ExclusionCriteria 
Details  1. Patient with type 1 diabetes mellitus
2. Keto acidosis
3. Pregnant women.
4. Patients with CKD as comorbid condition
5. Patient with stroke psychiatric disorders, neurological disorders, nephrology, hepatology, oncological, respiratory disorders, infectious disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Annual Rate of number of prescriptions of type of anti-diabetic medications in T2DM with Acute MI.  At admission and discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Demographic factors
Other antidiabetic drug
Co-morbidities
Cardiovascular medications
ASCVD (IHD, stroke), heart failure
Residence type
Habits
Laboratory parameters
 		 At admission and discharge 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
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)   03/08/2024 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Type II Diabetes Mellitus (T2DM) is a prevalent condition with reduced quality of life and increased mortality rates. Insulin resistance and relative insulin insufficiency are the main factors defining T2DM. Over 462 million people worldwide live with T2DM and it is a global growing disease burden. Even though metformin is consistently advised as the first-line medication for the treatment of T2DM, clinical guidelines have advised since January 2017 that the presence comorbidities specifically, cardiovascular disease, heart failure (HF), in addition to hypoglycemia should be taken into consideration when choosing a second-line therapy. The purpose of this study is to investigate trends in the annual prescription rate of anti-diabetic medications in patients with ASCVD and HF during the period 2019-2023. 
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