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

Phase 4

Completed

• Conditions: Empagliflozin; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Hypoglycemic Agents
• Interventions: Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I); Drug: Empagliflozin 10 MG

• Registration Number: NCT06145360
• Lead Sponsor: SINA Health Education and Welfare Trust

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Study Start: 2023-12-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I)	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.
Empagliflozin 10mg	Empagliflozin 10 MG	Group A: Empagliflozin 10 mg once daily with antidiabetic drugs

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Weight in Kg	12 weeks	Number of participants reduces weight in Kg during the therapy or mean reduction in weight overtime

Trial Locations

Locations (1)

SINA Shireen Jinnah colony; 🇵🇰 Karachi, Pakistan