Bridge Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-75
SponsorHK inno.N Corporation

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

Treatment groups

110 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators