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

• Status: Not yet recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Metformin

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