NCT02753803

Brief Summary

A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 27, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

April 25, 2016

Last Update Submit

September 15, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • AUC

    area under the concentration-time curve

    1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose

Study Arms (6)

A group

EXPERIMENTAL

Evogliptin Pioglitazone Evogliptin+Pioglitazone

Drug: Evogliptin, Pioglitazone, Evogliptin+Pioglitazone

B group

EXPERIMENTAL

Pioglitazone Evogliptin Evogliptin+Pioglitazone

Drug: Pioglitazone, Evogliptin, Evogliptin+Pioglitazone

C group

EXPERIMENTAL

Evogliptin Evogliptin+Pioglitazone Pioglitazone

Drug: Evogliptin, Evogliptin+Pioglitazone, Pioglitazone

D group

EXPERIMENTAL

Pioglitazone Evogliptin+Pioglitazone Evogliptin

Drug: Pioglitazone, Evogliptin+Pioglitazone, Evogliptin

E group

EXPERIMENTAL

Evogliptin+Pioglitazone Evogliptin Pioglitazone

Drug: Evogliptin+Pioglitazone, Evogliptin, Pioglitazone

F group

EXPERIMENTAL

Evogliptin+Pioglitazone Pioglitazone Evogliptin

Drug: Evogliptin+Pioglitazone, Pioglitazone, Evogliptin

Interventions

Evogliptin, Pioglitazone, Evogliptin+PioglitazoneDRUG

Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD

Also known as: Suganon, Actos
A group
Pioglitazone, Evogliptin, Evogliptin+PioglitazoneDRUG

Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD

Also known as: Suganon, Actos
B group
Evogliptin, Evogliptin+Pioglitazone, PioglitazoneDRUG

Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD

Also known as: Suganon, Actos
C group
Pioglitazone, Evogliptin+Pioglitazone, EvogliptinDRUG

Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD

Also known as: Suganon, Actos
D group
Evogliptin+Pioglitazone, Evogliptin, PioglitazoneDRUG

Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD

Also known as: Suganon, Actos
E group
Evogliptin+Pioglitazone, Pioglitazone, EvogliptinDRUG

Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD

Also known as: Suganon, Actos
F group

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Male Volunteers (Age: 19\~45years)
  • \<Body Weight\<90, 18\<BMI\<27
  • FPG: 70-125 mg/dL

You may not qualify if:

  • galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Clinically significant Medical History
  • Allergy or Drug Hypersensitivity
  • AST(SGOT), ALT(SGPT) \> Upper Normal Range\*1.5, eGFR\<80 mL/min
  • Drink during clinical trial period
  • Smoking during clinical trial period
  • Grapefruit/Caffeine intake during clinical trial period
  • No Contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials Center, Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-onePioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kyung-Sang Yu, M.D., Ph.D.

    Clinical Trials Center, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

April 28, 2016

Study Start

July 27, 2016

Primary Completion

October 19, 2016

Study Completion

March 10, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

KR(1)