Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating PEGylated Loxenatide Injection（PEX168）Combined With Metformin in the Treatment of Type 2 Diabetes Mellitus
This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study that will enroll approximately 564 T2DM patients who before screening have inadequately controlled blood glucose （7.0%≤HbA1c≤10.5% at randomization）despite at least 8 weeks of metformin monotherapy at stable doses（≥1500 mg/day).
Subjects will be randomized to receive either PEX168 100μg, 200μg or PEX 168 Dummy Injection
as add-on to metformin hydrochloride. The baseline HbA1c level （HbA1c≤8.5% or HbA1c>8.5）is
designed as the stratification factor based on which a dynamic randomization will be
performed.
This study consists of 4 periods： Period 1：Up to 3 weeks of screening period. Period 2：A
4-week PEX168 dummy injection run-in period. Period 3：A 52-week treatment period (including
a 24-week core treatment period and a 28-week extended treatment period).
Period 4: A 30-day safety follow-up period.
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