Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

Chungbuk National University Hospital300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Diabetes Mellitus, Type 2

Interventions

Empagliflozin 25 MGDRUG

Empagliflozin 25mg/day add-on to triple combination oral antidiabetic agents consisted with metformin, glimepiride, and DPP4 inhibitor

INSDRUG

Basal insulin add on the background OADs

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes in HbA1c From Baseline to months 36

Changes in HbA1c From Baseline to months 36 (3-year)

Time frame: Baseline, month 36 (3-year)

Secondary Outcomes

Achievement of target HbA1c

Percentage of Patients Who Achieved Glycemic Target of HbA1c at month 36

Time frame: Baseline, month 36

Changes in HbA1c

Changes in HbA1c From Baseline to each time frame

Time frame: Baseline, month 3, 6, 12, 18, 24, 30

Changes in FPG

Changes in fasting plasma glucose level from baseline to each month

Time frame: 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

Time frame: Baseline, month 36

Changes in body weight

Changes in body weight from baseline to month 36

Time frame: Baseline, month 36

Changes in blood pressure

Changes in systolic and diastolic blood pressure from baseline to month 36

Time frame: Baseline, month 36

Percentage of patients with hypoglycemic episodes

All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.

Time frame: Baseline, month 36

Data from ClinicalTrials.gov

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