A Clinical Trial to Evaluate the Preference Regarding Convenience of Medication and Efficacy/Safety of SUGAMET®XR Tablet 5/1000mg

Dong-A ST

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus; Metabolic Disease; Renal Disease; Diabetes Mellitus, Type 2; Endocrine System Diseases

Treatments: Drug: Evogliptin 5mg/Metformin 1000mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04653779

DA1229_01_DM_IV

Details and patient eligibility

About

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

Enrollment: 54 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Group A

Experimental group

Description:

Patients receive Evogliptin 5mg/Metformin 1000mg once a day

Treatment:

Drug: Evogliptin 5mg/Metformin 1000mg