Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab.

February 15, 2021 updated by: Dong-A ST Co., Ltd.

Multi-center, Open, Non-intervention and Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab. in Patients With Type 2 Diabetes

Multi-center, open, non-intervention and observational study to Evaluate the efficacy and safety of Suganon tab. or Sugamet XR tab. in patients with Type 2 diabetes

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1971

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
    • Nowon-gu
      • Seoul, Nowon-gu, Korea, Republic of, 01757
        • Recruiting
        • Sanggye paik pospital
        • Contact:

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

Probability Sample

Study Population

Type 2 DM patients

Description

Inclusion Criteria:

  1. The subject is aged ≥19 years
  2. The subject has type 2 diabetes mellitus

Exclusion Criteria:

1. The subject has a contraindication

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Patients who receive Double therapy or Insulin
Drug: Evogliptin
Evogliptin
Other Names:
  • Suganon
  • Sugamet XR
Group B
Patients who receive DPP-4 inhibitor
Drug: Evogliptin
Evogliptin
Other Names:
  • Suganon
  • Sugamet XR
Group C
Drug-naïve patients
Drug: Metformin and Evogliptin
Metformin and Evogliptin
Other Names:
  • Suganon
  • Sugamet XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: at 12 weeks
To assess change from baseline in HbA1c
at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: at 24 weeks
To assess change from baseline in HbA1c
at 24 weeks
The percentage of patients with HbA1c <7.0% and <6.5%
Time Frame: at 12 and 24 weeks
To assess the percentage of patients with HbA1c <7.0% and <6.5%
at 12 and 24 weeks
Change in FPG
Time Frame: at 12 and 24 weeks
To assess change from baseline in fasting plasma glucose (FPG)
at 12 and 24 weeks

Collaborators and Investigators

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

Sponsor

Dong-A ST Co., Ltd.

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)

March 25, 2020

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA1229_DM_OS

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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