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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Glucose Metabolism Disorders Diabetes Mellitus, Type 2 Hypoglycemic Agents Empagliflozin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Empagliflozin 10mg

Group A: Empagliflozin 10 mg once daily with antidiabetic drugs

Group Type EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Insulin+Metformin+DPP4 inhibitor (DPP4I)

Intervention Type DRUG

Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care

Interventions

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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

Intervention Type DRUG

Insulin+Metformin+DPP4 inhibitor (DPP4I)

Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care

Intervention Type DRUG

Other Intervention Names

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EMPAA

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No