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CompletedNCT02949193Updated Oct 31, 2016

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

A Phase 3 interventional study of evogliptin and Sitagliptin in Type 2 Diabetes Mellitus, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-31.

Sponsored by Dong-A ST Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
222
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description
  1. Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.
  2. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.
02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 222 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects with 6.5%≤HbA1c≤11.0% at screening
  • Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening
  • Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion criteria

Exclusion Criteria:

  • Subjects with fasting plasma glucose≥270mg/dL at screening
  • Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
  • Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
  • Subjects with ALT and AST 2.5 times or higher than upper normal range
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
222 participants (actual)

Study arms

  • Experimental
    evogliptin

    evogliptin 5mg qd add-on to metformin

    Drug: evogliptin

  • Active comparator
    sitagliptin

    sitagliptin 100mg qd add-on to metformin

    Drug: Sitagliptin

Interventions

  • Drugevogliptin

    evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg

    Also known as: Suganon

  • DrugSitagliptin

    sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg

    Also known as: januvia

06

What researchers measure

Primary outcomes

  1. HbA1c

    unit: %

    Time frame: Change from baseline at 24 week

Secondary outcomes

  1. fasting plasma glucose

    unit : mg/dL

    Time frame: Change from baseline at 24 week

  2. HOMA-beta

    unit: %

    Time frame: Change from baseline at 24 week

  3. HbA1c response rate

    unit: %

    Time frame: Change from baseline at 24 weeks

07

Study locations

1 site
  • Kangbuk Samsung Medical Center
    Seoul, 110-746, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02949193
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Oct 31, 2016
Start date
May 2013
Primary completion
Nov 2014
Completion
May 2015
Last update
Oct 31, 2016

Study contacts

Sung Woo Park, M.D., Ph.D.
principal investigator · Kangbuk Samsung Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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