This study is a multi-center, randomized, open-label, parallel, positive-controlled registered clinical study,to evaluate the efficacy and safety of insulin degludec injection developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
344
long-acting insulin
long-acting insulin
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe Second Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGChange value of glycosylated hemoglobin (HbA1c)
Change value of HbA1c from baseline following 26 weeks of therapy
Time frame: Baseline and 26 weeks
Percentage of patients achieving HbA1c ≤7% or HbA1c ≤6.5%
Percentage of patients in each arm achieving HbA1c ≤7% or HbA1c ≤6.5% after 26 weeks of treatment.
Time frame: Baseline, week 26
Change value of HbA1c
Change value of HbA1c from baseline following 14 weeks of therapy
Time frame: Baseline, week 14
Change value of fasting blood glucose
Change value of fasting blood glucose following 14 and 26 weeks of therapy
Time frame: Baseline, week 14, week 26
Adverse events (AEs) and serious adverse events (SAEs)
AEs and SAEs and their incidence during the 26-week treatment period, and then determine the correlation with the drug
Time frame: Baseline to week 26
Hypoglycemia
Frequency of severe or symptomatic hypoglycemia during the 26-week treatment period
Time frame: Baseline to week 26
Immunogenicity
The occurrence of immunogenicity during the 26-week treatment period by detecting Anti-Drug-Antibody(ADA).
Time frame: Baseline, week 14, week 26
Abnormal findings
Abnormal findings during the 26-week treatment period,including abnormal findings of blood routine test,blood biochemical test as well as other abnormal laboratory findings.
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Time frame: Baseline to week 26