Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

Sponsor
Dong-A ST Co., Ltd.
Study ID
NCT02949193
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • evogliptin — DRUG
    evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg
  • Sitagliptin — DRUG
    sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg

Study Details

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Key Dates

First listed
Oct 31, 2016
Start date
May 31, 2013
Status verified
Oct 2016
Primary completion
Nov 30, 2014
Completion
May 31, 2015

Study Design

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

Arms

  • Experimental: evogliptin
    evogliptin 5mg qd add-on to metformin
  • Active Comparator: sitagliptin
    sitagliptin 100mg qd add-on to metformin

Primary Outcome Measure

HbA1c [ Time Frame: Change from baseline at 24 week ]

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