The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.

Sponsor
Daewoong Pharmaceutical Co. LTD.
Study ID
NCT04634500
Phase
PHASE3
Status
Completed

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

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

Interventions

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
Nov 18, 2020
Status verified
Oct 2022
Primary completion
Nov 3, 2021
Completion
Nov 3, 2021

Study Design

Enrollment
200 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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