Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05103306

Acronym

LUCID

Enrollment

300

Registered

2021-11-02

Start date

2017-01-31

Completion date

2022-12-31

Last updated

2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus, Sodium-glucose co-transporter 2 inhibitor, Empagliflozin, Insulin glargine, Insulin degludec

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

Interventions

DRUGEmpagliflozin 25 MG

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

DRUGINS

Basal insulin add on the background OADs

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Changes in HbA1c	Baseline, month 3, 6, 12, 18, 24, 30	Changes in HbA1c From Baseline to each time frame
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 lipid profiles	Baseline, month 36	Changes in total cholesterol, triglyceride, HDL-cholesterol and LDL cholesterol from baseline to month 36
Achievement of target HbA1c	Baseline, month 36	Percentage of Patients Who Achieved Glycemic Target of HbA1c at month 36
Changes in blood pressure	Baseline, month 36	Changes in systolic and diastolic blood pressure from baseline to month 36
Percentage of patients with hypoglycemic episodes	Baseline, month 36	All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.
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 body weight	Baseline, month 36	Changes in body weight from baseline to month 36

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026