Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy

• Status: Recruiting
• Trial end date: 2023-04-29
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PegBio Co., Ltd.

Criteria

Inclusion Criteria:

• Male or female, aged 18~75 years old;

• T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,<1500mg) constantly for at least 8 consecutive weeks;

• 7.5% ≤ HbA1c ≤ 10.0% at screening;

• 18.5 kg/m2 < BMI < 40.0 kg/m2 at screening;

Exclusion Criteria:

• Any anti-diabetic therapy other than Metformin within 8 weeks before screening；

• T1DM;

• Received insulin therapy more than 14 days within 1 year before screening;

• Female who is pregnant, breast-feeding;

• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol;

• History of acute diabetic complications, such as diabetic ketoacidosis or hyperglycemic hyperosmolar status within 6 months before screening；

• History or presence of pancreatitis (acute or chronic);

• Presence or history of malignant neoplasms within the past 5 years prior to the day of screening