NCT02946541

Brief Summary

This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2013

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

Study Start

First participant enrolled

July 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

February 23, 2014

Last Update Submit

March 26, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

DA-1229evogliptinDPP-IV inhibitorSuganonDPP-4 inhibitor

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    unit: %

    Change from baseline at 24 weeks

Secondary Outcomes (2)

  • fasting plasma glucose

    Change from baseline at 24 weeks

  • HbA1c response rate

    Change from baseline at 24 weeks

Study Arms (2)

evogliptin 5mg

EXPERIMENTAL

evogliptin 5mg QD

Drug: evogliptin 5mg

placebo

PLACEBO COMPARATOR

Placebo QD

Drug: Placebo

Interventions

evogliptin 5mgDRUG

evogliptin 5mg, QD

Also known as: DA-1229, Suganon
evogliptin 5mg
PlaceboDRUG

Placebo, QD

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with 6.5%≤HbA1c≤10.0% at screening
  • Subjects untreated with oral hypoglycemic agents within 6 weeks prior to screening
  • Subjects with 6.5%≤HbA1c≤10.0% at Visit 2
  • Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangdong Sacred Heart Hospital

Seoul, 134-701, 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-one

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Doo Man Kim, M.D., Ph.D.

    Kangdong Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2014

First Posted

October 27, 2016

Study Start

July 1, 2013

Primary Completion

October 1, 2014

Study Completion

April 1, 2015

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)