Teneligliptin Versus Linagliptin in Diabetes Mellitus Typ... | NCT03011177

Studies
Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

NCT03011177

Sponsor

Handok Inc.

Status

Completed

Last Update Posted

Feb 22, 2019Actual

Enrollment

168Actual

Phase

Phase 4

Conditions

Type2 Diabetes Mellitus

Interventions

Teneligliptin
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

Feb 2019

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

Jan 2017Actual

Primary Completion Date

Sep 2018Actual

Completion Date

Sep 2018Actual

First Submitted Date

Jan 3, 2017

First Submission Date that Met QC Criteria

Jan 4, 2017

First Posted Date

Jan 5, 2017Estimated

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

Feb 20, 2019

Last Update Posted Date

Feb 22, 2019Actual

Description Module

Brief Summary

To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients.

Detailed Description

A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study

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

168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
teneligliptin	Experimental	teneligliptin 20mg qd	Drug: Teneligliptin
linagliptin	Active Comparator	linagliptin 5mg qd	Drug: Linagliptin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teneligliptin	Drug	teneligliptin 20mg qd	teneligliptin
Linagliptin

Measure	Description	Time Frame
HbA1c		12week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are 19 years or older on screening
Patients with type 2 diabetes mellitus
Patients with 7.0% ≤ HbA1c ≤ 11.0% at the screening visit
Patients with Fasting Plasma Glucose <15mmol/L(270mg/dL) on screening

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 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
Asan Medical Center		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C579035	3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
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