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Clinical Trials/NCT04326166
NCT04326166
Unknown
Not Applicable

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

Dong-A ST Co., Ltd.1 site in 1 country1,971 target enrollmentMarch 25, 2020

Overview

Phase
Not Applicable
Intervention
Evogliptin
Conditions
Diabetes Mellitus, Type 2
Sponsor
Dong-A ST Co., Ltd.
Enrollment
1971
Locations
1
Primary Endpoint
Change in HbA1c
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 25, 2020
End Date
July 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • The subject has a contraindication

Arms & Interventions

Group A

Patients who receive Double therapy or Insulin

Intervention: Evogliptin

Group B

Patients who receive DPP-4 inhibitor

Intervention: Evogliptin

Group C

Drug-naïve patients

Intervention: Metformin and Evogliptin

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: at 12 weeks

To assess change from baseline in HbA1c

Secondary Outcomes

  • Change in HbA1c(at 24 weeks)
  • Change in FPG(at 12 and 24 weeks)
  • The percentage of patients with HbA1c <7.0% and <6.5%(at 12 and 24 weeks)

Study Sites (1)

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