NCT02949193

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started May 2013

Typical duration for phase_3 type-2-diabetes-mellitus

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

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

February 23, 2014

Last Update Submit

October 27, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    unit: %

    Change from baseline at 24 week

Secondary Outcomes (3)

  • fasting plasma glucose

    Change from baseline at 24 week

  • HOMA-beta

    Change from baseline at 24 week

  • HbA1c response rate

    Change from baseline at 24 weeks

Study Arms (2)

evogliptin

EXPERIMENTAL

evogliptin 5mg qd add-on to metformin

Drug: evogliptin

sitagliptin

ACTIVE COMPARATOR

sitagliptin 100mg qd add-on to metformin

Drug: Sitagliptin

Interventions

evogliptinDRUG

evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg

Also known as: Suganon
evogliptin
SitagliptinDRUG

sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg

Also known as: januvia
sitagliptin

Eligibility Criteria

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

You may qualify if:

  • 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

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)

Kangbuk Samsung Medical Center

Seoul, 110-746, 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-oneSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Sung Woo Park, M.D., Ph.D.

    Kangbuk Samsung 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 31, 2016

Study Start

May 1, 2013

Primary Completion

November 1, 2014

Study Completion

May 1, 2015

Last Updated

October 31, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)