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

Chungbuk National University Hospital200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Diabetes Mellitus, Type 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes in HbA1c From Baseline to Week 24

Time frame: Baseline, Week 24

Changes in Fasting Plasma Glucose From Baseline to Week 24

Time frame: Baseline, Week 24

Secondary Outcomes

Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24

Time frame: Baseline, Week 24

Changes in HbA1c From Baseline to Week 12

Time frame: Baseline, Week 12

Changes in Fasting Plasma Glucose From Baseline to Week 12

Time frame: Baseline, Week 24

Changes in Weight Between Baseline and Week 24

Time frame: Baseline, Week 24

Changes in Body Mass Index Between Baseline and Week 24

Time frame: Baseline, Week 24

Changes in Total Cholesterol Between Baseline and Week 24

Time frame: Baseline, Week 24

Changes in HDL Cholesterol Between Baseline and Week 24

Time frame: Baseline, Week 24

Changes in LDL Cholesterol Between Baseline and Week 24

Time frame: Baseline, Week 24

Changes in Triglycerides Between Baseline and Week 24

Time frame: Baseline, Week 24

Data from ClinicalTrials.gov

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