Type 2 Diabetes Mellitus (T2DM)
Conditions
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.
Interventions
DRUGGLP-1 receptor agonist
PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).
DRUGPlacebo
PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.
Sponsors
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 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | week 1, week 25 | Change in HbA1c from baseline(week 1) to week 25 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Below 7.0% | week 1, week 25 | Percentage of participants with HbA1c below 7.0% was evaluated at week 25. |
| Change in Body Weight (kg) | week 1, week 25 | Change from baseline (week 1) in body weight 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 |
| Change in Body Mass Index | week 1, week 25 | Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25. |
Countries
China
Outcome results
None listed