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 in drug-naïve subjects with T2DM.
Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period. 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 active drug or placebo at a 3:1 active drug:placebo ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
251
60 eligible patients will be included in this group
60 eligible patients will be included in this group
60 eligible patients will be included in this group
Peking University People's Hospital
Beijing, China
Change of glycosylated hemoglobin(HbA1c)
Change of HbA1c from baseline value to end of treatment
Time frame: 12 weeks
Percentage of patients achieving HbA1c <7%
Percentage of patients achieving HbA1c \<7% at Week 12
Time frame: 12 weeks
Percentage of patients achieving HbA1c ≤6.5%
Percentage of patients achieving HbA1c ≤6.5% at Week 12
Time frame: 12 weeks
HbA1c
Changes of HbA1c from baseline value at Weeks 2, 4, and 8
Time frame: 2, 4, and 8 weeks
Fasting plasma glucose(FPG)
Changes of fasting plasma glucose(FPG) from baseline value at Weeks 2, 4, 8, and 12.
Time frame: 2, 4, 8, and 12 weeks
2-hour postprandial glucose(2-h PPG)
Changes of 2-hour postprandial glucose(2-h PPG) from baseline value at Weeks 4, 8, and 12.
Time frame: 4, 8, and 12 weeks
Insulin
Changes of insulin from baseline value at Weeks 4, 8, and 12
Time frame: 4, 8, and 12 weeks
C-peptide
Changes of C-peptide from baseline value at Weeks 4, 8, and 12
Time frame: 4, 8, and 12 weeks
Self-monitoring of blood glucose (SMBG)
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60 eligible patients will be included in this group
Changes of mean profile and mean increments from baseline value of the 7-point SMBG
Time frame: 4, 8, and 12 weeks