Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy (LUCID)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Empagliflozin 25 MG; Drug: INS

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 Type: Observational
• Enrollment (Anticipated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Type 2 diabetes, uncontrolled with triple OADs

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Triple OADs failure; Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor	Drug: Empagliflozin 25 MG; Empagliflozin 25mg/day add-on to triple combination oral antidiabetic agents consisted with metformin, glimepiride, and DPP4 inhibitor; Drug: INS; Basal insulin add on the background OADs; Other Names: Basal insulin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chungbuk National University Hospital
• Investigators: Principal Investigator: Eu Jeong Ku, MD, PhD, Chungbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Empagliflozin; Type 2 diabetes mellitus; Sodium-glucose co-transporter 2 inhibitor; Insulin glargine; Insulin degludec
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: CBNUH-LUCID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No