Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

Diabetes Mellitus, Type 2 Clinical Trial

— LUCID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05103306
• Other study ID #: CBNUH-LUCID
• Status: Active, not recruiting
• Start date: January 2017
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Chungbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Empagliflozin 25 MG
Empagliflozin 25mg/day add-on to triple combination oral antidiabetic agents consisted with metformin, glimepiride, and DPP4 inhibitor
• INS
Basal insulin add on the background OADs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chungbuk National University Hospital

Outcome

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