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
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
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
Parallel
IN-B00009
DrugTest drug
Placebo
DrugPlacebo drug
A change in HbA1c from baseline at Week 24
A change in HbA1c from baseline at each time point at Weeks 4, 8, 12, and 16
Proportion of subjects with HbA1c <7% at week 24
Proportion of subjects with HbA1c ≤6.5% at week 24
A change in glucose metabolism indicators from baseline at week 24
FPG, fasting insulin, HOMA-IR, HOMA-β (However, percent changes in fasting insulin, HOMA-IR, and HOMA-β are also presented)
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This trial is not recruiting at the moment. You can still explore other options:
