Status
Completed
Phase
Phase 3
Enrollment
620
Locations
1
Results
Not posted
Publications
0
Study 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.
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 metformin monotherapy. Patients will be assessed for eligibility over a 2 week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period and a 28-week open-label treatment period. The eligible patients will be randomized to PB-119 or placebo cohort at a 1:1 ratio for the first 24-week. Patients in PB-119 group will subsequently be given active drug and patients in placebo group will take placebo, all patients in two groups will remain metformin background therapy. In the 28-week open-label period, all patients will be administered active drugs. After that, there will be a 4-week follow-up period; All randomized patients will be taken blood samples for the pharmacokinetic (PK) analysis.
Interventions
DRUG
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).
DRUG
PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.
Timeline
First posted
Aug 7, 2020
Study start
Jun 23, 2020
Primary completion
Sep 15, 2022
Study completion
May 26, 2023
Results posted
Not reported
Registry updated
Jul 28, 2023
Outcomes
Change in HbA1c
Time frame · week 1, week 25
Change in HbA1c from baseline(week 1) to week 25
HbA1c Below 7.0%
Time frame · week 1, week 25
Percentage of participants with HbA1c below 7.0% was evaluated at week 25.
Change in Body Weight (kg)
Time frame · week 1, week 25
Change from baseline (week 1) in body weight was evaluated at week 25
Change in Fasting Plasma Glucose (FPG)
Time frame · week 1, week 25
Change from baseline (week 1) in FPG was evaluated at week 25
Change in Body Mass Index
Time frame · week 1, week 25
Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.
Eligibility
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
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Beijing University People's Hospital
Beijing, Beijing Municipality, China
Publications
No PMID-linked publications were present in this registry snapshot.
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