Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

NCT ID: NCT05103306

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Triple OADs failure

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

Empagliflozin 25 MG

Intervention Type DRUG

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

INS

Intervention Type DRUG

Basal insulin add on the background OADs

Interventions

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Empagliflozin 25 MG

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

Intervention Type DRUG

INS

Basal insulin add on the background OADs

Intervention Type DRUG

Other Intervention Names

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Basal insulin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chungbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eu Jeong Ku

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eu Jeong Ku, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

References

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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.

Reference Type DERIVED
PMID: 37369826 (View on PubMed)

Other Identifiers

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CBNUH-LUCID

Identifier Type: -

Identifier Source: org_study_id

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