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

  NCT04326166

  Unknown statusObservationalUpdated Feb 17, 2021
• Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin Compared With Dapagliflozin Added on Metformin Alone or Diabetes Medication Naïve Patient in Type 2 Diabetes Mellitus (Stable II Study)

  NCT03202563

  CompletedInterventionalPhase 4Updated Feb 15, 2019
• A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers

  NCT02375139

  CompletedInterventionalPhase 1Updated Jul 22, 2015
• A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes

  NCT06972732

  RecruitingInterventionalPhase 4Updated Sep 15, 2025
• A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fasting State

  NCT03939143

  CompletedInterventionalPhase 1Updated May 20, 2020
• Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

  NCT04170998

  CompletedInterventionalPhase 3Updated Dec 10, 2021

ClinicalTrials.gov ID

NCT04653779

Lead Sponsor

Dong-A ST Co., Ltd.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

54Estimated

Last Update Posted

Dec 11, 2020Actual

Start Date

Dec 2020Estimated

Primary Completion Date

May 2021Estimated

Completion Date

Jul 2021Estimated

Official Title

A Multi-center, Open-label, Single-arm, Phase IV Clinical Trial to Evaluate the Preference Regarding Convenience of Medication, Efficacy and Safety After Switching to SUGAMET®XR Tablet 5/1000mg in Patients With Type 2 Diabetes and Renal Diseases

Brief Summary

Multi-center, open-label, single arm study to Evaluate the preference regarding convenience of medication, efficacy and safety of Sugamet XR tab. 5/1000mg in patients with Type 2 diabetes and renal diseases

• Diabetes Mellitus, Type 2
• Renal Disease
• Diabetes Mellitus
• Metabolic Disease
• Endocrine System Diseases

• Evogliptin 5mg/Metformin 1000mg

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Aged ≥60 years
• Subjects with type 2 diabetes mellitus
• Subjects treated with DPP-4 inhibitor and 1,000mg/day dose of metformin 1T/qd for at least 8 weeks prior to screening
• Subjects with HbA1c≤7.5% at screening
• Subjects with 45mL/min/1.73m2≤eGFR≤90mL/min/1.73m2 at screening
• Subjects with fasting glucose≤200 at screening
• Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

• Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
• ESRD or Patients who have kidney dialysis
• Subjects with ALT and AST 3 times or higher than upper normal range

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Dong-A ST Co., Ltd.INDUSTRY

82-32-340-1236