| 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
|
|
|
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
|
|
|
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. |