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

SINA Health Education and Welfare Trust

Status and phase: Completed; Phase 4

Conditions: Glucose Metabolism Disorders; Empagliflozin; Hypoglycemic Agents; Diabetes Mellitus, Type 2

Treatments: Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I); Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06145360

00003

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Empagliflozin 10mg

Experimental group

Description:

Group A: Empagliflozin 10 mg once daily with antidiabetic drugs

Treatment:

Drug: Empagliflozin 10 MG

regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I)

Active Comparator group

Description:

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

Treatment:

Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I)