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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06145360
• Other study ID #: 00003
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2023
• Source: SINA Health Education and Welfare Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Metabolism Disorders
• Hypoglycemic Agents
• Metabolic Diseases

Intervention

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

Locations

Country	Name	City	State
Pakistan	SINA Shireen Jinnah colony	Karachi

Sponsors (2)

Lead Sponsor	Collaborator
SINA Health Education and Welfare Trust	Horizon Pharmaceutical Pvt Ltd

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight in Kg	Number of participants reduces weight in Kg during the therapy or mean reduction in weight overtime	12 weeks
Secondary	BMI in kg/m2	Number of participants reduces BMI kg/m2 or mean reduction in BMI overtime	12 weeks
Secondary	systolic blood pressure and diastolic blood pressure	systolic blood pressure and diastolic blood pressure measure in mmHg during the therapy	12 weeks