Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

NCT05103306 | Unknown DMC

• 1 other identifier: CBNUH-LUCID
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1c From Baseline to months 36

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

  Baseline, month 36 (3-year)

Secondary Outcomes (8)

• Achievement of target HbA1c

  Baseline, month 36

• Changes in HbA1c

  Baseline, month 3, 6, 12, 18, 24, 30

• Changes in FPG

  Baseline, month 3, 6, 12, 18, 24, 30, 36

• Changes in lipid profiles

  Baseline, month 36

• Changes in body weight

  Baseline, month 36

Study Arms (1)

Triple OADs failure

Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor

Drug: Empagliflozin 25 MG; Drug: INS

Interventions

Empagliflozin 25 MG DRUG

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

Triple OADs failure

INS DRUG

Basal insulin add on the background OADs

Also known as: Basal insulin

Triple OADs failure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 2 diabetes, uncontrolled with triple OADs

You may qualify if:

• Inadequately controlled with triple OADs (metformin, glimepiride, dipeptidyl peptidase-4 inhibitor) showing HbA1c 7.5-12.0%

You may not qualify if:

• 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

Sponsors & Collaborators

• Chungbuk National University Hospital: lead

Related Publications (1)

• Ku EJ, Oh TK. Long-Term Effectiveness of Quadruple Combination Therapy with Empagliflozin Versus Basal Long-Acting Insulin Therapy in Patients with Type 2 Diabetes: 3-Year Retrospective Observational Study. Diabetes Ther. 2023 Sep;14(9):1471-1479. doi: 10.1007/s13300-023-01437-x. Epub 2023 Jun 27.

  PMID: 37369826 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eu Jeong Ku, MD, PhD

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 2, 2021
• Study Start: January 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07