This is a study to evaluate the impact and efficacy of Efsubaglutide Alfa injection 3mg QoW on the treatment of type 2 diabetes patients with poor glycemic control after dietary and exercise intervention. Primary objective: To evaluate the effect and role of continuous treatment with 3mg of Efsubaglutide Alfa QoW and 1mg of Efsubaglutide Alfa QW for 12 weeks on HbA1c in T2DM patients with poor glycemic control after dietary and exercise intervention. Secondary objectives: 1. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on glucose variability (change in time in range (TIR) relative to baseline) in T2DM patients with poor glycemic control after dietary and exercise intervention. 2. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on drug exposure (relative to 1mg QW) in T2DM patients with poor glycemic control after dietary and exercise intervention. 3. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on fasting plasma glucose (FPG) in T2DM patients with poor glycemic control after dietary and exercise intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Efsubaglutide Alfa 3mg/0.5ml
Efsubaglutide Alfa 1mg/0.5ml
Nanjing First Hospital
Nanjing, Jiangsu, China
CangZhou Hospital of Integrated TCM and Western Medicine in Hebei Province
Cangzhou, China
Huzhou Central Hospital
Huzhou, China
Jiangsu Province Offical Hospital
Nanjing, China
Ningbo First Hospital
Ningbo, China
Ningbo Medical Center Lihuili Hospital
Ningbo, China
The First Affiliated Hospital of Soochow University
Suzhou, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Wenzhou Central Hospital
Wenzhou, China
Zibo Municipal Hospital
Zibo, China
HbA1c
The change in mean HbA1c concentrations (%)from baseline with Efsubaglutide Alfa 3mg QoW versus Efsubaglutide Alfa 1mg QW
Time frame: 12 weeks
TIR
Changes in the percentage of time in range (TIR) relative to baseline
Time frame: 12 weeks
HbA1c<7.0% and <6.5%
The proportion of participants who achieved HbA1c target (HbA1c\<7.0% and \<6.5% Patient percentage)
Time frame: 12 weeks
fasting lipid profiles
Changes in fasting lipid(TC/TG/HDL-C/LDL-C) profiles relative to baseline(mmol/L)
Time frame: 12 weeks
weight
Weight change from baseline(kg)
Time frame: 12 weeks
waist circumference
Absolute changes in waist circumference(cm) from baseline
Time frame: 12 weeks
hip circumference
Absolute changes in hip circumference(cm) from baseline
Time frame: 12 weeks
waist-to-hip ratio (WHR)
Absolute changes in waist-to-hip ratio (WHR) from baseline
Time frame: 12 weeks
salvage treatment
Percentage of subjects receiving salvage treatment(%)
Time frame: 12 weeks
body fat composition
Changes in body fat composition from baseline
Time frame: 12 weeks
FPG
Changes in FPG (mmol/L) relative to baseline
Time frame: 12 weeks
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