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

Sponsor
SINA Health Education and Welfare Trust
Study ID
NCT06145360
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    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) — DRUG
    Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Nov 2023
Primary completion
Mar 1, 2024
Completion
Mar 1, 2024

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin 10mg
    Group A: Empagliflozin 10 mg once daily with antidiabetic drugs
  • Active Comparator: regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I)
    Group B: usual care group \[Insulin+Metformin+DPP4 inhibitor (DPP4I)\] but without Empagliflozin with adjustment of therapy as the standard of care.

Primary Outcome Measure

Number of participants achieved HbA1c level i.e. <7% [ Time Frame: 12 weeks ]

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