NCT02974504

Brief Summary

A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV clinical trial to investigate the effect on blood glucose of evogliptin after oral administration in patients with type 2 diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

November 23, 2016

Last Update Submit

July 19, 2018

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    unit: %

    Change from baseline at 12 week

Secondary Outcomes (2)

  • fasting plasma glucose

    Change from baseline at 12 week

  • HbA1c response rate

    Change from baseline at 12 weeks

Study Arms (2)

evogliptin

EXPERIMENTAL

evogliptin 5mg qd

Drug: evogliptin

linagliptin

ACTIVE COMPARATOR

linagliptin 5mg qd

Drug: Linagliptin

Interventions

evogliptinDRUG

evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg

evogliptin
LinagliptinDRUG

linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg

Also known as: Tragenta
linagliptin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with 7.0%≤HbA1c≤10.0% at screening
  • Subjects untreated with oral hypoglycemic agents within 8 weeks prior to screening
  • 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 24 weeks prior to screening
  • Subjects with ALT and AST 3 times or higher than upper normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, South Korea

Location

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Design

Study Type
interventional
Phase
phase 4
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

November 23, 2016

First Posted

November 28, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 23, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)