Phase IV Clinical Trial to Investigate the Effect on Bloo... | NCT02974504

Studies
Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)

NCT02974504

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Jul 23, 2018Actual

Enrollment

207Actual

Phase

Phase 4

Conditions

Type2 Diabetes

Interventions

evogliptin
Linagliptin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Mar 2018Actual

Completion Date

Mar 2018Actual

First Submitted Date

Nov 23, 2016

First Submission Date that Met QC Criteria

Nov 23, 2016

First Posted Date

Nov 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2018

Last Update Posted Date

Jul 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-24 weeks.
Liniagliptin 5mg Group: Administration with linagliptin 5mg for 0-12 weeks, and with Evogliptin 5mg for 13-24 weeks

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

207Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
evogliptin	Experimental	evogliptin 5mg qd	Drug: evogliptin
linagliptin	Active Comparator	linagliptin 5mg qd	Drug: Linagliptin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
evogliptin	Drug	evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg	evogliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c	unit: %	Change from baseline at 12 week

Secondary Outcomes

Measure	Description	Time Frame
fasting plasma glucose	unit : mg/dL	Change from baseline at 12 week
HbA1c response rate	unit: %	Change from baseline at 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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 24 weeks prior to screening
Subjects with ALT and AST 3 times or higher than upper normal range

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C557982	4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one
D000069476	Linagliptin

Ancestor Terms

ID	Term
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided