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

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Metformin and Evogliptin; Drug: Evogliptin

• Registration Number: NCT04326166
• Lead Sponsor: Dong-A ST Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-25
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-17
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1971

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group C	Metformin and Evogliptin	Drug-naïve patients
Group A	Evogliptin	Patients who receive Double therapy or Insulin
Group B	Evogliptin	Patients who receive DPP-4 inhibitor

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	at 12 weeks	To assess change from baseline in HbA1c

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	at 24 weeks	To assess change from baseline in HbA1c
Change in FPG	at 12 and 24 weeks	To assess change from baseline in fasting plasma glucose (FPG)
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%

Trial Locations

Locations (1)

Sanggye paik pospital; 🇰🇷 Seoul, Nowon-gu, Korea, Republic of