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

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504396
• Other study ID #: PB119302
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2020
• Est. completion date: May 26, 2023

Study information

• Verified date: July 2023
• Source: PegBio Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: May 26, 2023
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Drug:
• 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).
• Placebo
PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.

Locations

Country	Name	City	State
China	Beijing University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
PegBio Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change in HbA1c from baseline(week 1) to week 25	week 1, week 25
Secondary	HbA1c Below 7.0%	Percentage of participants with HbA1c below 7.0% was evaluated at week 25.	week 1, week 25
Secondary	Change in Body Weight (kg)	Change from baseline (week 1) in body weight was evaluated at week 25	week 1, week 25
Secondary	Change in Fasting Plasma Glucose (FPG)	Change from baseline (week 1) in FPG was evaluated at week 25	week 1, week 25
Secondary	Change in Body Mass Index	Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.	week 1, week 25