RecruitingPhase 4NCT07442006

Glycemic Variability of Combination Therapies in T2DM

A Multicenter Study to Evaluate Efficacy and Safety


Sponsor

JW Pharmaceutical

Enrollment

178 participants

Start Date

Oct 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Glycemic Variability of Combination Therapies in T2DM


Eligibility

Min Age: 19 Years

Inclusion Criteria1

  • Inadequate glycemic control despite treatment with Metformin (≥ 1,000mg/day) and SGLT-2 inhibitor.

Exclusion Criteria4

  • History of acute or chronic metabolic acidosis
  • Moderate to severe renal impairment (eGFR \< 45 mL/min/1.73m²)
  • Severe hepatic impairment
  • History of heart failure (NYHA Class III/IV)

Interventions

DRUGMetformin

500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)

DRUGEmpagliflozin/Linagliptin

10/5 mg, for 12 weeks (PO, QD)

DRUGEmpagliflozin/Metformin

5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)

DRUGAnagliptin

100 mg, for 12 weeks (PO, BID)


Locations(1)

The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator

Seoul, South Korea

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NCT07442006


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