Glycemic Variability of Combination Therapies in T2DM

Sponsor
JW Pharmaceutical
Study ID
NCT07442006
Phase
PHASE4
Status
Recruiting
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Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin/Metformin — DRUG
    5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)
  • Anagliptin — DRUG
    100 mg, for 12 weeks (PO, BID)
  • Metformin — DRUG
    500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)
  • Empagliflozin/Linagliptin — DRUG
    10/5 mg, for 12 weeks (PO, QD)

Study Details

Glycemic Variability of Combination Therapies in T2DM

Key Dates

Start date
Oct 29, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
178 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Empagliflozin/Metformin + Anagliptin
  • Active Comparator: Active Comparator
    Metformin + Empagliflozin/Linagliptin

Primary Outcome Measure

Mean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12 [ Time Frame: Baseline to week 12 ]

Central Contacts

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