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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06145360
Other study ID # 00003
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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