Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

Study Overview
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Brief Summary
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This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

Detailed Description
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This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

Official Title
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Long-term Effectiveness and Safety of Empagliflozin-based Quadruple Oral Antidiabetic Agents Therapy Compared to Basal Insulin-based Combination Therapy in Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Empagliflozin 25 MG
* Drug: INS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inadequately controlled with triple OADs (metformin, glimepiride, dipeptidyl peptidase-4 inhibitor) showing HbA1c 7.5-12.0% Exclusion Criteria: Type 1 diabetes Gestional diabetes Diabetes due to secondary causes Receiving anticancer treatment Receiving glucocorticoids or immune-suppressants Have been treated with sodium glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering the study Have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Triple OADs failure<br>Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor | Drug: Empagliflozin 25 MG<br>* Empagliflozin 25mg/day add-on to triple combination oral antidiabetic agents consisted with metformin, glimepiride, and DPP4 inhibitor<br>Drug: INS<br>* Basal insulin add on the background OADs<br>* Other names: Basal insulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1c From Baseline to months 36 | Changes in HbA1c From Baseline to months 36 (3-year) | Baseline, month 36 (3-year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of target HbA1c | Percentage of Patients Who Achieved Glycemic Target of HbA1c at month 36 | Baseline, month 36 | 
| Changes in HbA1c | Changes in HbA1c From Baseline to each time frame | Baseline, month 3, 6, 12, 18, 24, 30 | 
| Changes in FPG | Changes in fasting plasma glucose level from baseline to each month | Baseline, month 3, 6, 12, 18, 24, 30, 36 | 
| Changes in lipid profiles | Changes in total cholesterol, triglyceride, HDL-cholesterol and LDL cholesterol from baseline to month 36 | Baseline, month 36 | 
| Changes in body weight | Changes in body weight from baseline to month 36 | Baseline, month 36 | 
| Changes in blood pressure | Changes in systolic and diastolic blood pressure from baseline to month 36 | Baseline, month 36 | 
| Percentage of patients with hypoglycemic episodes | All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected. | Baseline, month 36 | 
| Percentage of patients with at least 1 episode of genitourinary tract infections | Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections | Baseline, month 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Sodium-glucose co-transporter 2 inhibitor, Empagliflozin, Insulin glargine, Insulin degludec