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
Overview
- Phase
- Phase 3
- Intervention
- GLP-1 receptor agonist
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Sponsor
- PegBio Co., Ltd.
- Enrollment
- 620
- Locations
- 1
- Primary Endpoint
- Change in HbA1c
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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；
- •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
Arms & Interventions
PB-119 once-weekly-subcutaneous injection
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.
Intervention: GLP-1 receptor agonist
Placebo once-weekly-subcutaneous injection
PB-119 150μg matched placebo which will be used in placebo group for 24 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in HbA1c
Time Frame: week 1, week 25
Change in HbA1c from baseline(week 1) to week 25
Secondary Outcomes
- Change in Body Weight (kg)(week 1, week 25)
- Change in Body Mass Index(week 1, week 25)
- HbA1c Below 7.0%(week 1, week 25)
- Change in Fasting Plasma Glucose (FPG)(week 1, week 25)