Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

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

Details

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

Criteria

Inclusion Criteria:

• Subjects with 7.0%≤HbA1c≤10.0% at screening

• Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening

• Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening

• Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion Criteria:

• Subjects with fasting plasma glucose≥240mg/dL at screening

• Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus

• Subject with ALT and AST 3 times or higher than upper normal range

• Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening