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
NCT06145360 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2024-04-08
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.
Conditions
- Glucose Metabolism Disorders
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Empagliflozin
Interventions
- 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
- DRUG
-
Insulin+Metformin+DPP4 inhibitor (DPP4I)
Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care
Sponsors & Collaborators
-
Horizon Pharmaceutical Pvt Ltd
collaborator UNKNOWN -
SINA Health Education and Welfare Trust
lead OTHER
Principal Investigators
-
Hina Sharif, Pharm-D,MSPH · SINA Health Education & Welfare Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-01
- Primary Completion
- 2024-03-01
- Completion
- 2024-03-01
Countries
- Pakistan
Study Locations
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