| Trial ID: | L1884 |
| Source ID: | NCT06145360
|
| Associated Drug: |
Empagliflozin 10 Mg
|
| Title: |
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
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Glucose Metabolism Disorders|Diabetes Mellitus, Type 2|Hypoglycemic Agents|Empagliflozin
|
| Interventions: |
DRUG: Empagliflozin 10 MG|DRUG: Insulin+Metformin+DPP4 inhibitor (DPP4I)
|
| Outcome Measures: |
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|BMI in kg/m2, Number of participants reduces BMI kg/m2 or mean reduction in BMI overtime, 12 weeks|systolic blood pressure and diastolic blood pressure, systolic blood pressure and diastolic blood pressure measure in mmHg during the therapy, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: SINA Health Education and Welfare Trust | Collaborators: Horizon Pharmaceutical Pvt Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-12-01
|
| Completion Date: |
2024-03-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-08
|
| Locations: |
SINA Shireen Jinnah colony, Karachi, Pakistan
|
| URL: |
https://clinicaltrials.gov/show/NCT06145360
|
