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

NCT ID: NCT04267601

Last Updated: 2021-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2448 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-06

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Anagliptin

Anagliptin treatment for 24weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bucheon-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JWP-GDL-402

Identifier Type: -

Identifier Source: org_study_id

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