Empagliflozin-based Quadruple Combination vs Insulin Glarine-based Combination Therapy in Patients With Type 2 Diabetes

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

Official Title
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Efficacy and Safety of Empagliflozin vs. Insulin Glargine add-on Therapy in Patients With Inadequately Controlled Type 2 Diabetes Under Triple Combination Therapy

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are inadequately controlled with triple OADs (metformin, sulfonylurea, dipeptidyl peptidase inhibitor) as evidenced by HbA1c >7.5% and <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 |
| --- | --- |
| EMPA<br>Empagliflozin 25 mg/day | |
| INS<br>Insulin Glargine dose-titrated | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1c From Baseline to Week 24 |  | Baseline, Week 24 | 
| Changes in Fasting Plasma Glucose From Baseline to Week 24 |  | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24 |  | Baseline, Week 24 | 
| Changes in HbA1c From Baseline to Week 12 |  | Baseline, Week 12 | 
| Changes in Fasting Plasma Glucose From Baseline to Week 12 |  | Baseline, Week 24 | 
| Changes in Weight Between Baseline and Week 24 |  | Baseline, Week 24 | 
| Changes in Body Mass Index Between Baseline and Week 24 |  | Baseline, Week 24 | 
| Changes in Total Cholesterol Between Baseline and Week 24 |  | Baseline, Week 24 | 
| Changes in HDL Cholesterol Between Baseline and Week 24 |  | Baseline, Week 24 | 
| Changes in LDL Cholesterol Between Baseline and Week 24 |  | Baseline, Week 24 | 
| Changes in Triglycerides Between Baseline and Week 24 |  | Baseline, Week 24 | 
| Changes in Systolic Blood Pressure Between Baseline and Week 24 |  | Baseline, Week 24 | 
| Changes in Dystolic Blood Pressure Between Baseline and Week 24 |  | Baseline, Week 24 | 
| Percentage of Patients With Hypoglycemia Episodes Between Baseline and Week 24 | All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected. | Baseline, Week 24 | 
| Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections Between Baseline and Week 24 |  | Baseline, Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Sodium glucose cotransporter 2 inhibitor, Empagliflozin, Insulin glargine