Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Empagliflozin 25 MG; Drug: INS

• Registration Number: NCT05103306
• Lead Sponsor: Chungbuk National University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2017-01
• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-02
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Triple OADs failure	Empagliflozin 25 MG	Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor
Triple OADs failure	INS	Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor

Primary Outcome Measures

Name	Time	Method
Changes in HbA1c From Baseline to months 36	Baseline, month 36 (3-year)	Changes in HbA1c From Baseline to months 36 (3-year)

Secondary Outcome Measures

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