The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin

Sponsor
Daewoong Pharmaceutical Co. LTD.
Study ID
NCT05505994
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • DWP16001 — DRUG
    DWP16001 A mg tablet
  • Dapagliflozin — DRUG
    Dapagliflozin tablet
  • DWP16001 Placebo — DRUG
    DWP16001 Placebo tablet
  • Dapagliflozin Placebo — DRUG
    Dapagliflozin Placebo tablet

Study Details

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Key Dates

Start date
Sep 28, 2022
Status verified
Apr 2024
Primary completion
Feb 26, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
340 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study group
    DWP16001 A mg, Dapagliflozin placebo
  • Active Comparator: Control group
    DWP16001 A mg placebo, Dapagliflozin

Primary Outcome Measure

Change from baseline in HbA1c [ Time Frame: at 24 weeks ]

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