A phase 2, multicenter study to evaluate the efficacy and safety of twelve once weekly subcutaneous doses of PB-119 to patients with type 2 diabetes mellitus (T2DM) not well-controlled by metformin mono therapy.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses 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 and a 12-week double-blind treatment period.A phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of twelve once weekly subcutaneous doses of PB-119 to patients with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy The eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C). Each patient will subsequently be randomized within the designated cohort to 1) active drug or placebo at a 3:1 active drug:placebo ratio and 2) exclusion from or inclusion in the pharmacokinetic (PK) blood sample collection subgroup at a 3:1 excluded:included ratio
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
214
Each patient will subsequently be randomized within the designated cohort to active drug or placebo
Each patient will subsequently be randomized within the designated cohort to active drug or placebo
Each patient will subsequently be randomized within the designated cohort to active drug or placebo
Clinical Pharmacology of Miami
Miami, Florida, United States
The change from baseline value of HbA1c will be compared between treatments
Time frame: From Baseline to end of treatment (up to Week 12)
The change from baseline value of Fasting Plasma Glucose at Weeks 2, 4, 8, and 12
Time frame: From Baseline to end of treatment (up to Week 12)
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Each patient will subsequently be randomized within the designated cohort to active drug or placebo