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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04326166
Collaborator
(none)
1,971
Enrollment
1
Location
16.2
Anticipated Duration (Months)
121.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
1971 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Mar 25, 2020
Anticipated Primary Completion Date :
Jul 31, 2021
Anticipated Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in HbA1c [at 12 weeks]

      To assess change from baseline in HbA1c

    Secondary Outcome Measures

    1. Change in HbA1c [at 24 weeks]

      To assess change from baseline in HbA1c

    2. The percentage of patients with HbA1c <7.0% and <6.5% [at 12 and 24 weeks]

      To assess the percentage of patients with HbA1c <7.0% and <6.5%

    3. Change in FPG [at 12 and 24 weeks]

      To assess change from baseline in fasting plasma glucose (FPG)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sanggye paik pospital Seoul Nowon-gu Korea, Republic of 01757

    Sponsors and Collaborators

    • Dong-A ST Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A ST Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04326166
    Other Study ID Numbers:
    • DA1229_DM_OS
    First Posted:
    Mar 30, 2020
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Metformin

    Study Results

    No Results Posted as of Feb 17, 2021