Efficacy and Safety of Evogliptin add-on to Metformin in... | NCT02949193

Studies
Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

NCT02949193

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Oct 31, 2016Estimated

Enrollment

222Actual

Phase

Phase 3

Conditions

Type 2 Diabetes Mellitus

Interventions

evogliptin
Sitagliptin

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

Oct 2016

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

May 2013

Primary Completion Date

Nov 2014Actual

Completion Date

May 2015Actual

First Submitted Date

Feb 23, 2014

First Submission Date that Met QC Criteria

Oct 27, 2016

First Posted Date

Oct 31, 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

Oct 27, 2016

Last Update Posted Date

Oct 31, 2016Estimated

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

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Detailed Description

Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.
Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

222Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
evogliptin	Experimental	evogliptin 5mg qd add-on to metformin	Drug: evogliptin
sitagliptin	Active Comparator	sitagliptin 100mg qd add-on to metformin	Drug: Sitagliptin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
evogliptin	Drug	evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg	evogliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c	unit: %	Change from baseline at 24 week

Secondary Outcomes

Measure	Description	Time Frame
fasting plasma glucose	unit : mg/dL	Change from baseline at 24 week
HOMA-beta	unit: %	Change from baseline at 24 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with 6.5%≤HbA1c≤11.0% at screening
Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before 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 6 months prior to screening
Subjects with ALT and AST 2.5 times or higher than upper normal range

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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

Name	Affiliation	Role
Sung Woo Park, M.D., Ph.D.	Kangbuk Samsung Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangbuk Samsung Medical Center		Seoul		110-746	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

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

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
D000068900	Sitagliptin Phosphate

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided