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CompletedNCT02375139Updated Jul 22, 2015

A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers

A Phase 1 interventional study of DA-1229_01 and E+M in Type 2 Diabetes Mellitus, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-22.

Sponsored by Dong-A ST Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study summary

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 36 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 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
19 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age between 19 to 45, healthy male subjects(at screening)
  • Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
  • FPG 60-125mg/dL glucose level(at screening)
  • Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion criteria

Exclusion Criteria:

  • Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
  • Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
  • Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
  • Subject who already participated in other trials in 2 months
  • Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    DA-1229_01 → E+M

    DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg

    Drug: DA-1229_01 · Drug: E+M

  • Experimental
    E+M → DA-1229_01

    DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg

    Drug: DA-1229_01 · Drug: E+M

Interventions

  • DrugDA-1229_01

    complex single administration

    Also known as: Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets

  • DrugE+M

    co-administration of 2 drugs

    Also known as: Evogliptin 5 mg + Metformin XR 1000 mg

06

What researchers measure

Primary outcomes

  1. Area Under Curve(AUC)last of Evogliptin and Metformin

    Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

  2. Maximum of concentration (Cmax) of Evogliptin and Metformin

    Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

Secondary outcomes

  1. Time of maximum concentration(Tmax) of Evogliptin and Metformin

    Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

  2. Terminal half-life(t1/2) of Evogliptin and Metformin

    Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

  3. Apparent Clearance(CL/F) of Evogliptin and Metformin

    Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

  4. Area Under Curve(AUC)inf of Evogliptin and Metformin

    AUCinf = AUC last + Clast/λz

    Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

07

Study locations

1 site
  • Clinical Trial Center, Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02375139
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Mar 2, 2015
Start date
Apr 2015
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jul 22, 2015

Study contacts

Kyung-sang Yu, Ph.D, M.B.A
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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