Korean Observational Study to Evaluate the Efficacy and Safety of Anagliptin Switching From Other DPP4is in type2 DM (SSUG)

April 28, 2021 updated by: JW Pharmaceutical

A Non-interventional, Single Group, Open-label, Multicenter Observational Study to Evaluate the Efficacy and Safety of Anagliptin in Type 2 Diabetic Patients With Other DPP4is as Mono or Combination Therapy With Insufficient Glucose Control

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects will visit the site on the 12th week (Visit 2) and 24th week (Visit 3) from the registration date (Visit 1) to confirm the efficacy and safety.

Primary endpoint

- HbA1c change after 24 weeks treatment

Secondary endpoint

  • Average rate of change in HbA1c after baseline
  • Ratio of subjects with HbA1c<7% after 24 weeks
  • Ratio of subjects with HbA1c<6.5% after 24 weeks
  • Subgroup analysis by gender, age, BMI, medical history, renal function, liver function, conventional DPP4 inhibitors therapy, concomitant Oral Antidiabetic Drug, duration of disease

Safety endpoint : Adverse Event

Study Type

Observational

Enrollment (Actual)

2448

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 14647
        • The Catholic University of Korea, Bucheon ST. Mary's hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 19 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

Exclusion Criteria:

  • Prior exposure to Anagliptin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of HbA1C
Time Frame: after 24weeks treatment
after 24weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2017

Primary Completion (Actual)

March 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWP-GDL-402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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