Clinical trial
A Multicenter, Randomized, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of PB-119 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone
Name
PB119302
Description
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.
Trial arms
Trial start
2020-06-23
Estimated PCD
2022-09-15
Trial end
2023-05-26
Status
Completed
Phase
Early phase I
Treatment
GLP-1 receptor agonist
PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).
Arms:
PB-119 once-weekly-subcutaneous injection
Placebo
PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.
Arms:
Placebo once-weekly-subcutaneous injection
Other names:
PB-119 Placebo
Size
620
Primary endpoint
Change in HbA1c
week 1, week 25
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 620, 'type': 'ACTUAL'}}
Updated at
2023-07-28
1 organization
1 product
1 drug
1 indication
Organization
PegBioProduct
GLP-1 receptor agonistIndication
Type 2 Diabetes MellitusDrug
Varlilumab