Status:
COMPLETED
Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy
Lead Sponsor:
PegBio Co., Ltd.
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 wel...
Detailed Description
This is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of PB-119 to patients with T2DM not well-controlled by metfo...
Eligibility Criteria
Inclusion
- 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;
- 5% ≤ HbA1c ≤ 10.0% at screening;
- 5 kg/m2 \< BMI \< 40.0 kg/m2 at screening;
Exclusion
- 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
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2023
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT04504396
Start Date
June 23 2020
End Date
May 26 2023
Last Update
July 28 2023
Active Locations (1)
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1
Beijing University People's Hospital
Beijing, Beijing Municipality, China