Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 in Drug-naïve T2DM Subjects.
Detailed description
The study included a maximum 2-week screening period, a 4-week single-blind introduction period, a 24-week double-blind treatment period, a 28-week open extension treatment period, and a 4-week safety follow-up period. At the end of the single-blind entry period, eligible subjects were randomly assigned to two different administration groups in a 1:1 ratio and received a 24-week double-blind treatment. All subjects who completed the double-blind treatment entered the open extension treatment phase.Open extension treatment with subcutaneous injection of 150μg PB-119 once a week for 28 weeks. Safety follow-up was conducted 4 weeks after the end of treatment/completion of early exit visit in the open extension period.
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; * Confirmed T2DM patients meet the diagnostic criteria for type 2 diabetes published by WHO1999； * 18.5 kg/m2 \< BMI \< 40.0 kg/m2 at screening; * 7.5% ≤ HbA1c ≤ 11.0% at screening; * 7.0% ≤ HbA1c ≤ 10.5% when the random; * 18.5 kg/m2 \< BMI \< 40.0 kg/m2 during screening and before randomization
Exclusion criteria
* T1DM; * Continuous use of insulin for more than 14 days within 1 year before screening or before randomization； * Treatment with any dipeptidylpeptidase 4 (DPP-4) inhibitor or glucose-dependent insulin-stimulating peptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptor agonist prior to screening or randomized prior treatment； * Screening for any of the following heart diseases within the first 6 months or before randomization； * Patients whose hypertension was not effectively controlled during screening or before randomization (after resting ≥5 minutes, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)； * Serum amylase or lipase \>3×ULN or those with previous diagnosis of acute/chronic pancreatitis were screened or randomly screened； * Screening for severe trauma or infection that may affect glycemic control within the first month or before randomization； * A history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)； * Known to be allergic or intolerant to the study drug or metformin； * Female subjects during pregnancy or lactation.
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