The main purpose of this study is to investigate the efficacy and safety of JY09 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone
This study was designed as a multicenter, randomized, double-blind, placebo-parallel controlled Phase III clinical study to evaluate the efficacy and safety of Exendin-4Fc fusion protein (JY09) injection in adult subjects with type 2 diabetes mellitus (T2DM) who have poor glycemic control after dietary exercise intervention only. The proposed plan is to enroll 270 subjects with T2DM, using stratified block group randomization, with the stratification factor being baseline HbA1c (≤8.5% or \>8.5%), and randomly assign them to the 1.2 mg JY09 injection group (n=90 subjects), the 2.4 mg JY09 injection group (n=90 subjects), and the placebo group (n=90 subjects) in a 1:1:1 ratio. The trial was divided into 4 phases, i.e., a screening period of 2 weeks, a single-blind introduction period of 4 weeks, a treatment period of 54 weeks (26 weeks for the core treatment period and 28 weeks for the extended treatment period), and a safety follow-up period of 4 weeks. Total 64 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.
The first dose of 1.2 mg was administered subcutaneously in the abdomen, and after two weeks, the dose was adjusted to 2.4 mg, followed by a continuation of treatment for 52 weeks.
0.6 ml, placebo injection, biweekly subcutaneous abdominal injections for 26 weeks (core treatment period), after which placebo was randomized 1:1 to JY09 (1.2 mg) and JY09 (2.4 mg) continued subcutaneous abdominal injections biweekly for 28 weeks (extended treatment period).
Peking University People's Hospital
Beijing, Beijing Municipality, China
HbA1c
Change in glycated hemoglobin (HbA1c) values relative to baseline after 26 weeks of treatment.
Time frame: Baseline, Week 26
The proportion of HbA1c <6.5% and <7%
Proportion of subjects with HbA1c \<7% and HbA1c \<6.5% after 26 and 54 weeks of treatment.
Time frame: Baseline, Week 26,Week 54
HbA1c
Change in HbA1c relative to baseline after 6, 10, 14, 20, 38, and 54 weeks of treatment.
Time frame: Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54
fasting plasma glucose (FPG)
Change in fasting plasma glucose (FPG) relative to baseline after 6, 10, 14, 20, 38, and 54 weeks of treatment.
Time frame: Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54
fasting insulin
Change in fasting insulin relative to baseline after 14, 26, and 54 weeks of treatment.
Time frame: Baseline, Week 14,Week 26,Week 54
Homeostatic Model Assessment of Insulin Resistance(HOMA-IR)
Change in HOMA-IR relative to baseline after 26 and 54 weeks of treatment.
Time frame: Baseline,Week 26,Week 54
Health Survey Short Form (SF-36)
Value of change in Health Survey Short Form (SF-36) scores relative to baseline after 26 and 54 weeks of treatment.
Time frame: Baseline,Week 26,Week 54
blood pressure
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Change in blood pressure (sitting) relative to baseline after 26 and 54 weeks of treatment.
Time frame: Baseline,Week 26,Week 54