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

Sponsor
Dong-A ST Co., Ltd.
Study ID
NCT04170998
Phase
PHASE3
Status
Completed

Conditions

  • Type2 Diabetes

Eligibility Criteria

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

Interventions

  • Evogliptin 5mg — DRUG
    Participants receive Evogliptin 5mg orally once a day
  • Evogliptin Placebo — DRUG
    Participants receive placebo to match Evogliptin 5mg orally once a day
  • Dapagliflozin 10mg — DRUG
    Participants receive Dapagliflozin orally once a day
  • Metformin ≥ 1000mg — DRUG
    Metformin are administered at the same dose and formulation.

Study Details

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Key Dates

Start date
Jan 2, 2020
Status verified
Dec 2021
Primary completion
Jun 28, 2021
Completion
Dec 8, 2021

Study Design

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

Arms

  • Experimental: Evogliptin 5mg group
    Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
  • Placebo Comparator: Evogliptin Placebo group
    Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d

Primary Outcome Measure

Change from baseline in HbA1c (%) After 24 weeks [ Time Frame: 24 weeks ]

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