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.

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM), Cost-effectiveness, Sulfonylureas, DPP4 Inhibitors, Metformin
• Intervention / Treatment: Drug: sulfonylurease with metformin, DPP4 inhibitors with Metformin

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Dr. Sheuly Akter, MD; Phone Number: +880-1951208001; Email: dr.sheuly7314@gmail.com
• Study Contact Backup: Name: Md Sayedur Rahman, Professor; Phone Number: +880-197184757; Email: srkhasru@bsmmu.edu.bd

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • Recruiting
    • BSMMU
    • Contact: Dr. swapan Kumar Tapadar; Phone Number: 88029661064; Email: registrar@bsmmu.edu.bd
    • Principal Investigator: Dr. Sheuly Akter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients attending out patient department of BIRDEM General hospital,Shahbag, Dhaka, which is a tertiary care hospital and patients attending Siddhirganj Diabetic center, a secondary care level diabetes center

Description

Inclusion Criteria:

• New onset type2 diabetes mellitus diagnosed for 2 -5 years.
• Taking either sulfonylurea or DPP4 inhibitors combined with Metformin from the time of diagnosis.
• Age 18 years or above.
• Both male and female.
• Provided written informed consent.

Exclusion Criteria:

• Unwillingness to participate or unwillingness to give written informed consent.
• Patients on Insulin therapy or monotherapy with metformin since the time of diagnosis.
• Taking other than sulfonylurea or DPP4 inhibitors combined with Metformin from the time of diagnosis.
• Diabetes related complications at the time of diagnosis.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A- type 2 diabetic patients having sulfonylurease with metformin; Sulfonylurease- gliclazide(30/60/80mg), glimepiride (1/2/3/4mg), glibenclamide (5mg), glipizide (5mg) metformin - 500/850/1000mg	Drug: sulfonylurease with metformin, DPP4 inhibitors with Metformin; Oral hypoglycemic agents
Group B- type 2 diabetic patients having DPP4 inhibitors with metformin; DPP4 inhibitors- Linagliptin (2.5/5mg), Sitagliptin (50mg), Vildagliptin (50mg) metformin - 500/850/1000mg	Drug: sulfonylurease with metformin, DPP4 inhibitors with Metformin; Oral hypoglycemic agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c%	achievment of target HbA1 less than 7%	2-5years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin therapy	requirement of insulin therapy	2-5years
hospitalization	requirement of hospitalization	2-5years
3rd line therapy	addition of any 3rd drug	2-5years
nephropathy	development of nephropathy	2-5years

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Principal Investigator: Dr. Sheuly Akter, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Metformin; Dipeptidyl-Peptidase IV Inhibitors
• Other Study ID Numbers: 4575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No