Evaluating the Efficacy and Safety of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes and Obese Patient

Sponsor

SINA Health Education and Welfare Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT06145360

Collaborator

Horizon Pharmaceutical Pvt Ltd (Other)

150

Enrollment

Location

Arms

3.5

Anticipated Duration (Months)

43.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this study is to assess the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+Dipeptidyl peptidase 4 (DPP-4) inhibitors in poorly controlled type 2 diabetes mellitus (T2DM) patients. The study seeks to evaluate its effect on achieving glycemic goals in this patient population.

Condition or Disease	Intervention/Treatment	Phase
Glucose Metabolism Disorders Diabetes Mellitus, Type 2 Hypoglycemic Agents Empagliflozin	Drug: Empagliflozin 10 MG Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

An adaptive research design was judiciously employed to navigate the complexities of this research. Leveraging a secondary dataset, the study engaged data from registered diabetic patients who had been consistently monitored by SINA over the past six months. These existing datasets formed the foundation for analysis, enabling informed decision-making. Based on rigorous analytical evaluations, a standardized treatment protocol was established, with patients prescribed Empagliflozin 10mg for a duration of three monthsAn adaptive research design was judiciously employed to navigate the complexities of this research. Leveraging a secondary dataset, the study engaged data from registered diabetic patients who had been consistently monitored by SINA over the past six months. These existing datasets formed the foundation for analysis, enabling informed decision-making. Based on rigorous analytical evaluations, a standardized treatment protocol was established, with patients prescribed Empagliflozin 10mg for a duration of three months

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Effectivity of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes

Anticipated Study Start Date :

Dec 31, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Apr 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Empagliflozin 10mg Group A: Empagliflozin 10 mg once daily with antidiabetic drugs	Drug: Empagliflozin 10 MG the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I) in poorly controlled type 2 diabetes mellitus (T2DM Other Names: EMPAA
Active Comparator: regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I) Group B: usual care group [Insulin+Metformin+DPP4 inhibitor (DPP4I)] but without Empagliflozin with adjustment of therapy as the standard of care.	Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I) Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care

Arm

Intervention/Treatment

Experimental: Empagliflozin 10mg

Group A: Empagliflozin 10 mg once daily with antidiabetic drugs

Drug: Empagliflozin 10 MG

the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I) in poorly controlled type 2 diabetes mellitus (T2DM

Other Names:

EMPAA

Active Comparator: regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I)

Group B: usual care group [Insulin+Metformin+DPP4 inhibitor (DPP4I)] but without Empagliflozin with adjustment of therapy as the standard of care.

Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I)

Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care

Outcome Measures

Primary Outcome Measures

Number of participants achieved HbA1c level i.e. <7% [12 weeks]
The foremost objective is to determine whether the addition of Empagliflozin to the current treatment regimen leads to a significant improvement in glycemic control i.e. glycated haemoglobin less than 7% among poorly controlled T2DM patients in three months of treatment

Secondary Outcome Measures

Weight in Kg [12 weeks]
Number of participants reduces weight in Kg during the therapy or mean reduction in weight overtime
BMI in kg/m2 [12 weeks]
Number of participants reduces BMI kg/m2 or mean reduction in BMI overtime
systolic blood pressure and diastolic blood pressure [12 weeks]
systolic blood pressure and diastolic blood pressure measure in mmHg during the therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged 35 years or older, diagnosed with Type 2 Diabetes Mellitus,
Specifically, individuals with a documented HbA1c level equal to or exceeding 8.5% over the course of the last six months or more are considered eligible candidates.
these patients should currently be undergoing treatment involving a combination of Insulin and either Metformin or Sitagliptin.

Exclusion Criteria:

Patients with a history of recurrent urinary tract infections
those who are currently pregnant are excluded from participation in the study.
patients with an estimated Glomerular Filtration Rate (eGFR) exceeding 40 ml/min/1.73m²,
Furthermore, individuals with other concurrent medical conditions, and those who are unable to provide informed consent for the study, have also been excluded.