About this trial
This Phase 3 Bridge study is designed to evaluate the efficacy and safety of IN-B00009 Injection in Patients with T2DM Inadequately Controlled by Diet and Exercise Alone
Eligibility criteria
Qualifiers
Subjects aged 19 to 75 years at the time of written consent
Subjects with a BMI ≥ 20 kg/m² and ≤ 35 kg/m² at the screening visit
Those who have not administered hypoglycemic agents within the past 12 weeks
Those who have administered oral hypoglycemic agents within the past 12 weeks, but have not administered them within 5 weeks prior to the screening visit
Disqualifiers
Subjects who have been diagnosed with type 1 diabetes mellitus (T1DM) or diabetes due to a genetic defect or exocrine pancreatic dysfunction
Subjects who have been administered GLP-1 analogues or DPP-4 inhibitors within 12 weeks prior to the screening visit
Subjects who have used insulin within 24 weeks prior to the screening visit (excluding the short-term use for the treatment of hyperglycemia symptoms within a total of 14 days)
Subjects with a history of diabetic ketoacidosis, hyperosmolar hyperglycemia, or diabetic lactic acidosis within 24 weeks prior to the screening visit
Trial design
Treatments tested in this trial
- IN-B00009
- Placebo