NCT04267601

Brief Summary

This study was designed as a non-interventional, single-group, open-label, multicenter observational study for patients with type 2 diabetes in the real world clinical setting.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,448

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 6, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

3.7 years

First QC Date

February 11, 2020

Last Update Submit

April 28, 2021

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change of HbA1C

    after 24weeks treatment

Interventions

AnagliptinDRUG

Anagliptin treatment for 24weeks

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetic patients with other DPP4is as mono or combination therapy with insufficient glucose control

You may qualify if:

  • years of age at the time of consenting
  • Understands and is willing to sign an informed consent form (ICF)
  • HbA1c≥7.0%
  • within 7days before registration, continuing other DPP4is alone or combined therapy for than 8 weeks

You may not qualify if:

  • Prior exposure to Anagliptin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea, Bucheon ST. Mary's hopsital

Bucheon-si, 14647, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

anagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

July 6, 2017

Primary Completion

March 30, 2021

Study Completion

September 30, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)