Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGPB-119 100 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo
DRUGPB-119 150 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo
DRUGPB-119 200 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo
DRUGPB-119 placebo + Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo
Sponsors
Covance
PegBio Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients in whom T2DM has been diagnosed according to 2018 American Diabetes Association T2DM diagnostic criteria, have made lifestyle modifications (ie, diet and exercise) for at least 3 months prior to Screening, and have been taking metformin for at least 3 months before Screening with a stable dosage for at least 8 weeks (stable dosage is defined as metformin dosage ≥1500 mg/day or maximum tolerated dose). 2. Males and/or females between the ages of ≥18 and ≤70 years at Screening 3. HbA1c ≥7.5% and ≤11% at Screening and at Week -1, Visit 3.1; 4. FPG ≥126 and ≤240 mg/dL (≥7.0 and ≤13.3 mmol/L) at Screening and at Week -1, Visit 3.1; 5. Body mass index (BMI) ≥18.5 and ≤40.0 kg/m2 at Screening, with inclusion of patients with BMIs at the lower end of the range enrolled into the study to enable comparisons across BMI range;
Exclusion criteria
1. Medical history or current diagnosis of: 1. Type 1 diabetes mellitus, diabetes caused by pancreas injury or by other diseases (like acromegaly or Cushing syndrome); 2. Diabetes acute complication, like ketoacidosis or hyperosmolar coma; 3. Diagnosed proliferative retinopathy; 4. 3 instances of severe hypoglycemia (events during which the patient required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions; episodes may be associated with sufficient neuroglycopenia to have induced seizure or coma) in the 6 months prior to Screening; 5. Significant vascular disease; 2. Current/ongoing diagnosis of any type of malignant tumor or evidence of recurrence in the 6 months prior to Screening (patients who have been stable for ≥6 months or those who have had basal or squamous cell skin cancers removed and have no evidence of recurrence will not be excluded). Patients with a medical history of any other type of cancer in the last 5 years prior to Screening will be excluded; 3. Severe cardiovascular diseases occurring within 6 months prior to Screening (eg, congestive heart disease, myocardial infarction, acute coronary syndrome, apoplexy, transient ischemic attack);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline value of HbA1c will be compared between treatments | From Baseline to end of treatment (up to Week 12) |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline value of Fasting Plasma Glucose at Weeks 2, 4, 8, and 12 | From Baseline to end of treatment (up to Week 12) |
Countries
United States
Outcome results
None listed