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

PegBio

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: GLP-1 receptor agonist; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04504396

PB119302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 620 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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620 participants in 2 patient groups, including a placebo group

PB-119 once-weekly-subcutaneous injection

Experimental group

Description:

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.

Treatment:

Drug: GLP-1 receptor agonist

Placebo once-weekly-subcutaneous injection

Placebo Comparator group

Description:

PB-119 150μg matched placebo which will be used in placebo group for 24 weeks.

Treatment:

Drug: Placebo