NCT01529541

Brief Summary

This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

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

Timeline
Completed

Started May 2011

Longer than P75 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, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

February 6, 2012

Last Update Submit

May 12, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

CWP-0403SitagliptinMetformintype 2 DM

Outcome Measures

Primary Outcomes (1)

  • The Change in HbA1c from baseline to week24.

    0wk, 8wk, 16wk, 24wk

Secondary Outcomes (8)

  • The proportion of subjects achieving HbA1c<7% at week24

    0wk, 8wk, 16wk, 24wk

  • The proportion of subjects achieving HbA1c<6.5% at week24

    0wk, 8wk, 16wk, 24wk

  • The change from baseline to week 24: Fasting plasma glucose

    0wk, 24wk

  • change from baseline to week 24: Fasting serum insulin

    0wk, 24 wk

  • change from baseline to week 24 in Fasting serum pro-insulin

    0wk, 24wk

  • +3 more secondary outcomes

Study Arms (2)

Sitagliptin

ACTIVE COMPARATOR

Sitagliptin 100mg

Drug: Sitagliptin

CWP-0403

EXPERIMENTAL

CWP-0403 100mg

Drug: Anagliptin

Interventions

AnagliptinDRUG

Anagliptin 100mg, tablet, twice a day (BID)

CWP-0403
SitagliptinDRUG

Sitagliptin 100mg, tablet, once a day (QD)

Sitagliptin

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had diagnosed with type 2 DM before 3 months
  • Men and women between the age of ≥ 19 and ≤ 75 years
  • FPG ≤ 270 mg/dL at screening visit
  • Patients who consent to participate in this trial by written Informed Consent Form

You may not qualify if:

  • Type 1 DM or secondary diabetes
  • Subjects who are administrating oral anti-hyperglycemic drugs or have to take a medicine
  • Body mass index \< 20 kg/m2 or \> 40.0kg/m2
  • Subjects who are assessed to be inappropriate for this trial by investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

anagliptinSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 9, 2012

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

October 1, 2013

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

KR(1)