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CTRI Number  CTRI/2024/07/070298 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Use of statins and patient compliance with statin therapy among Type-2 diabetics patients with dyslipidemia 
Scientific Title of Study   Evaluation of Drug Utilization and Patient Compliance with Statin Therapy Among Type-2 Diabetes Mellitus Patients with Dyslipidemia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharanya Kotian 
Designation  PG Student  
Affiliation  NGSM Institute of pharmaceutical Sciences  
Address  Department of Pharmacy Practice NGSM Institute Of Pharmaceutical Sciences Paneer, Derlakatte, Mangaluru, Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9900574887  
Fax    
Email  sharanyakotian9911@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Juno J Joel 
Designation  Associate professor and Head 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice NGSM Institute Of Pharmaceutical Sciences Paneer, Derlakatte, Mangaluru, Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9480470727  
Fax    
Email  junojoel@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Adithi Kellarai 
Designation  Associate professor 
Affiliation  KS Hegde Medical Academy, NITTE (Deemed to be University) 
Address  Department of General Medicine K.S. Hegde Medical Academy Deralakatte, Mangaluru, Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9886517329  
Fax    
Email  adithibhandary@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice NGSM Institute Of Pharmaceutical Sciences,NITTE (Deemed to be University), Paneer, Derlakatte, Mangaluru, Karnataka 575018  
Justice KS Hegde Charitable Hospital, Derlakatte, Mangaluru, Karnataka 575018 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Adithi Kellarai  Justice K S Hegde Charitable Hospital  Department of General Medicine Justice K.S. Hegde Charitable Hospital Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA 
9900574887

adithibhandary@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 (NGSMIPS-IEC)  Approved 
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: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients aged 18 years and above diagnosed,Type 2 diabetes mellitus with dyslipidemia and are on statin therapy for a minimum of one month or more, in the Inpatient Department of General Medicine will be included in the study. 
 
ExclusionCriteria 
Details  Pregnant women, psychiatric illness patients, and cancer patients will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-Identifying the drug utilization and patient compliance with statin therapy.

 
8 months
 
 
Secondary Outcome  
Outcome  TimePoints 
-The glycemic control and diabetic complications among the study population.   8 Months 
-The drug-related problems among type 2 diabetes mellitus patients with dyslipidemia.  8 months 
 
Target Sample Size   Total Sample Size="143"
Sample Size from India="143" 
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)   22/07/2024 
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)   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  

INTRODUCTION

Diabetes mellitus is a persistent health condition characterized by increased blood sugar levels due to inadequate insulin production and resistance. Dyslipidemia refers to abnormalities in the lipids levels in the body. Insulin resistance in type 2 diabetes causes alterations in lipid metabolism despite normal LDL cholesterol levels, hence early management is necessary to lower the cardiovascular risk. Statins are the drug of choice for the management of dyslipidemia. Patient compliance with statin therapy is crucial to prevent the disease progression and related complications. With this background, the current study will evaluate drug utilization and patient compliance with statin therapy among type 2 diabetes mellitus patients with dyslipidemia.

Need of the Study

India is often referred to as the ‘Diabetes Capital of the World as it accounts for 17%percent of the total number of diabetes patients worldwide. Despite the availability of pharmacological treatments and established therapeutic guidelines, many patients still struggle to control high serum cholesterol levels. Adherence to statin therapy is closely linked to achieving the LDL cholesterol goal in patients with diabetes and dyslipidemia. Nevertheless, there is insufficient data on the adherence of diabetic patients to statin treatment in developing countries.  With this background the current study aims to evaluate the drug utilization pattern of statins and adherence in patients with type 2 diabetes mellitus with dyslipidemia.

OBJECTIVES

To evaluate the drug utilization and patient compliance with statin therapy among type 2 DM with dyslipidemia.

To assess the glycemic control and diabetic complications among the study population. 

To analyze the drug-related problems among type 2 diabetes mellitus patients with dyslipidemia.

METHODOLOGY

A prospective cross-sectional study will be conducted at the Department of General Medicine of a tertiary care hospital (Justice KS Hegde Charitable Hospital) with 143 patients for a period of 8 months. Patients aged 18 years and above diagnosed, with Type 2 diabetes mellitus with dyslipidemia and currently on statin therapy for a minimum of one month or more in the inpatient Department of General Medicine will be included in the study. The study parameters include demographic variables, and patient compliance (using patient compliance questionnaire). The drug utilization was measured in DDD/100 bed-days.

STATISTICAL ANALYSIS

Categorical data will be descriptively analyzed using SPSS version 29.

OUTCOME MEASURES

This study helps in identifying the drug utilization and patient compliance with statin therapy. This study assesses the glycemic control and diabetic complications among the study population. The study analyses the drug-related problems among type 2 diabetes mellitus patients with dyslipidemia.

 
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