Clinical trial 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
Official title: Effectivity of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glucose Metabolism Disorders
Diabetes Mellitus, Type 2
Hypoglycemic Agents
Empagliflozin
Keywords: Insulin Resistance
Type 2 Diabetes
Overweight
Add-on therapy
Glycemic control
Lead sponsor: SINA Health Education and Welfare Trust
Sponsor class: OTHER
Collaborators: name: Horizon Pharmaceutical Pvt Ltd
First posted: 2023-11-24
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: An adaptive research design was judiciously employed to navigate the complexities of this research. Leveraging a secondary dataset, the study engaged data from registered diabetic patients who had been consistently monitored by SINA over the past six months. These existing datasets formed the foundation for analysis, enabling informed decision-making. Based on rigorous analytical evaluations, a standardized treatment protocol was established, with patients prescribed Empagliflozin 10mg for a duration of three months
Primary purpose: TREATMENT

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+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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants achieved HbA1c level i.e. <7%
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight in Kg
timeFrame: 12 weeks
measure: BMI in kg/m2
timeFrame: 12 weeks
measure: systolic blood pressure and diastolic blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: SINA Shireen Jinnah colony
Study officials:
affiliation: SINA Health Education & Welfare Trust
name: Hina Sharif, Pharm-D,MSPH
role: PRINCIPAL_INVESTIGATOR
References: