Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

Sponsor
Chungbuk National University Hospital
Study ID
NCT05103306
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
Jul 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Triple OADs failure
    Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor

Primary Outcome Measure

Changes in HbA1c From Baseline to months 36 [ Time Frame: Baseline, month 36 (3-year) ]

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