Status:
COMPLETED
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
Lead Sponsor:
SINA Health Education and Welfare Trust
Collaborating Sponsors:
Horizon Pharmaceutical Pvt Ltd
Conditions:
Glucose Metabolism Disorders
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
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+Metfor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06145360
Start Date
December 1 2023
End Date
March 1 2024
Last Update
April 8 2024
Active Locations (1)
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1
SINA Shireen Jinnah colony
Karachi, Pakistan