Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570980
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Comparative Analysis of Cost-effectiveness Between Sulfonylureas and DPP4 Inhibitors in Combination With Metformin in Treatment of Type 2 Diabetic Patients A Retrospective Observational Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Analysis of Cost-effectiveness Between Sulfonylureas and DPP4 Inhibitors in Combination With Metformin in Treatment of Type 2 Diabetic Patients A Retrospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare the cost effectiveness of Sulfonylureas and DPP4-inhibitors in combination with Metformin among type2 diabetic patients diagnosed for 2-5 years Glycemic status and other clinical outcome are compared in between two groups and ICER are compared
Detailed Description:
Type 2 diabetes mellitus T2DM is a highly prevalent chronic disease Every 3 in 4 adults have diabetes in low and middle income countries Diabetes costs about 966 billion USD dollars in total health expenditure This is a huge economic burden for low and middle income countries where people have to pay out of their pocket for medical expense Type2 Diabetes is responsible for various serious life threatening complications like cardiovascular death retinopathy nephropathy stroke etc
Along with diet and exercise lifelong pharmacotherapy is needed But cost of drug is increasing day by day especially newer agents are very much expensive The aim of this study is to compare the cost and effectiveness of Metformin plus sulfonylureas with Metformin plus DPP4 inhibitors in management of type 2 diabetic patient This research will be conducted in Pharmacology department of Bangabandhu Sheikh Mujib Medical University BSMMU outpatient department of BIRDEM General Hospital and Siddhirganj diabetic center Narayanganj from the day of approval by IRB to July 2024 It will be multi centered retrospective observational cost-effectiveness study It will involve type 2 diabetic patients who have diagnosed for 2 years and taking either any of sulfonylurease or DPP4 inhibitors along with Metformin 206 patients will be enrolled 103 in each group One group will who are taking sulfonylureas with Metformin and another group will who are taking DPP4 inhibitors with Metformin Primary outcome will be glycemic control which will be measured by HbA1c and secondary outcome will be cardiovascular events like hypertension angina myocardial ischemia for which ECG and patients medical record will be analyzed nephropathy will be classified by eGFR insulin therapy and any hospitalization needed or not Data will be collected about various socio-demographic variables such as age sex education family history of diabetes other co morbidities Hypertension with diabetes will be considered in equal percentage in both groups Total direct medical cost like drug price hospitalization and cost of adverse drug reaction will be measured which will be actual medical cost of individual patient Then cost-effectiveness analysis will be done by ICER Descriptive statistics will be used for demographic variables Means standard deviation for ii continuous variables and number percentage for categorical variables will be used T test can be used to compare cost in two groups Chi-square test may be used to compare clinical outcome Price of drug will be obtained from BDNF 5th edition for particular brand of above mentioned drug in every individual patient This study will revealed whether there is significant difference in healthcare costs and clinical outcome between the above mentioned two groups This retrospective study will provide valuable insight about cost effectiveness of sulfonylureas and DPP4 inhibitors for the management of T2DM Healthcare providers even policymakers can be benefitted to take informed decision in patient care and formulary choices
Along with diet and exercise lifelong pharmacotherapy is needed But cost of drug is increasing day by day especially newer agents are very much expensive The aim of this study is to compare the cost and effectiveness of Metformin plus sulfonylureas with Metformin plus DPP4 inhibitors in management of type 2 diabetic patient This research will be conducted in Pharmacology department of Bangabandhu Sheikh Mujib Medical University BSMMU outpatient department of BIRDEM General Hospital and Siddhirganj diabetic center Narayanganj from the day of approval by IRB to July 2024 It will be multi centered retrospective observational cost-effectiveness study It will involve type 2 diabetic patients who have diagnosed for 2 years and taking either any of sulfonylurease or DPP4 inhibitors along with Metformin 206 patients will be enrolled 103 in each group One group will who are taking sulfonylureas with Metformin and another group will who are taking DPP4 inhibitors with Metformin Primary outcome will be glycemic control which will be measured by HbA1c and secondary outcome will be cardiovascular events like hypertension angina myocardial ischemia for which ECG and patients medical record will be analyzed nephropathy will be classified by eGFR insulin therapy and any hospitalization needed or not Data will be collected about various socio-demographic variables such as age sex education family history of diabetes other co morbidities Hypertension with diabetes will be considered in equal percentage in both groups Total direct medical cost like drug price hospitalization and cost of adverse drug reaction will be measured which will be actual medical cost of individual patient Then cost-effectiveness analysis will be done by ICER Descriptive statistics will be used for demographic variables Means standard deviation for ii continuous variables and number percentage for categorical variables will be used T test can be used to compare cost in two groups Chi-square test may be used to compare clinical outcome Price of drug will be obtained from BDNF 5th edition for particular brand of above mentioned drug in every individual patient This study will revealed whether there is significant difference in healthcare costs and clinical outcome between the above mentioned two groups This retrospective study will provide valuable insight about cost effectiveness of sulfonylureas and DPP4 inhibitors for the management of T2DM Healthcare providers even policymakers can be benefitted to take informed decision in patient care and formulary choices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None