Skip to main content
OpenTrials
Completed

NCT Number: NCT06145360

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glucose Metabolism Disorders Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Empagliflozin Endocrine System Diseases Hyperinsulinism Hypoglycemic Agents Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SINA Shireen Jinnah colony

Karachi, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empagliflozin 10 MG

Drug

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

Insulin+Metformin+DPP4 inhibitor (DPP4I)

Drug

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

Primary outcomes

  1. Number of participants achieved HbA1c level i.e. <7%

    Time frame: 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 outcomes

  1. Weight in Kg

    Time frame: 12 weeks

    Number of participants reduces weight in Kg during the therapy or mean reduction in weight overtime

  2. BMI in kg/m2

    Time frame: 12 weeks

    Number of participants reduces BMI kg/m2 or mean reduction in BMI overtime

  3. systolic blood pressure and diastolic blood pressure

    Time frame: 12 weeks

    systolic blood pressure and diastolic blood pressure measure in mmHg during the therapy

Sponsors and collaborators

Lead sponsor

SINA Health Education and Welfare Trust

Other

Collaborators

  • Horizon Pharmaceutical Pvt Ltd

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2023
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.