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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Interventions: Drug: GLP-1 receptor agonist; Drug: Placebo

• Registration Number: NCT04504396
• Lead Sponsor: PegBio Co., Ltd.

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 well-controlled by metformin monotherapy.

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 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.

Study Timeline

• Study Start: 2020-06-23
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Primary Completion: 2022-09-15
• Study Completion: 2023-05-26
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 620

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;

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PB-119 once-weekly-subcutaneous injection	GLP-1 receptor agonist	PB119 (polyethylene glycol exenatide) is a long-acting GLP-1RA for injection, which will be administered 150μg once-weekly subcutaneously to patients in active drug group for 24 weeks.
Placebo once-weekly-subcutaneous injection	Placebo	PB-119 150μg matched placebo which will be used in placebo group for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	week 1, week 25	Change in HbA1c from baseline(week 1) to week 25

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight (kg)	week 1, week 25	Change from baseline (week 1) in body weight was evaluated at week 25
Change in Body Mass Index	week 1, week 25	Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.
HbA1c Below 7.0%	week 1, week 25	Percentage of participants with HbA1c below 7.0% was evaluated at week 25.
Change in Fasting Plasma Glucose (FPG)	week 1, week 25	Change from baseline (week 1) in FPG was evaluated at week 25

Trial Locations

Locations (1)

Beijing University People's Hospital; 🇨🇳 Beijing, Beijing, China