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NCT04267601 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

— SSUG  

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04267601
Other study ID # JWP-GDL-402
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 6, 2017
Est. completion date September 30, 2021

Study information
Verified date April 2021
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2448
Est. completion date September 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Anagliptin
Anagliptin treatment for 24weeks

Locations
Country Name City State
Korea, Republic of The Catholic University of Korea, Bucheon ST. Mary's hopsital Bucheon

Sponsors (1)
Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of HbA1C after 24weeks treatment
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