Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Sponsor
Dong-A ST Co., Ltd.
Study ID
NCT04356742
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin 10mg — DRUG
    Dapagliflozin 10mg, orally, once daily, up to 24weeks
  • Placebo — DRUG
    Dapagliflozin Placebo, orally, once daily, up to 24weeks
  • Evogliptin 5mg — DRUG
    Evogliptin 5mg, orally, once daily for background therapy
  • Metformin≥1000mg — DRUG
    Metformin≥1000mg, orally, daily for background therapy

Study Details

This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.

Key Dates

Start date
May 26, 2020
Status verified
Mar 2022
Primary completion
Feb 23, 2022
Completion
Feb 23, 2022

Study Design

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

Arms

  • Experimental: Dapagliflozin 10mg + Evogliptin 5mg + Metformin
  • Placebo Comparator: Dapagliflozin Placebo + Evogliptin 5mg + Metformin

Primary Outcome Measure

Change from the baseline in HbA1c (%) after 24 weeks [ Time Frame: Baseline, 24 weeks ]

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