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

First listed
Nov 2, 2021
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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