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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan
    • SINA Shireen Jinnah colony

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants achieved HbA1c level i.e. <7%	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	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SINA Health Education and Welfare Trust
• Collaborators: Horizon Pharmaceutical Pvt Ltd
• Investigators: Principal Investigator: Hina Sharif, Pharm-D,MSPH, SINA Health Education & Welfare Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Insulin Resistance; Overweight; Type 2 Diabetes; Glycemic control; Add-on therapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Sodium-Glucose Transporter 2 Inhibitors; Metformin; Empagliflozin; Dipeptidyl-Peptidase IV Inhibitors
• Other Study ID Numbers: 00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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