The study is being conducted to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with oral antidiabetic drugs compared to insulin Glargine QD for 26+26 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
513
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial
Peking University People's Hospital
Beijing, Beijing Municipality, China
Change in HbA1c
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
Time frame: Week 0 to Week 26
Change in FPG(fasting plasma glucose)
Change from baseline in FPG after 26 weeks and 52 weeks of treatment
Time frame: Week 0 to Week 26, Week 0 to Week 52
Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%
Proportion of subjects with HbA1c\<7% and HbA1c≤6.5% after 26 weeks and 52 weeks of treatment
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Proportion of Subjects achieving HbA1c targets (HbA1c<7%; HbA1c≤6.5%) and without grade 2 or 3 hypoglycaemia in the last 12 weeks of the treatment period
Time frame: Week 0 to Week 26, Week 0 to Week 52
Change in HbA1c
Time frame: Week 0 to Week 52
per-breakfast SMPG
Time frame: Week 0 to Week 26 、Week 0 to Week 52
8-point SMPG profiles
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Average daily Insulin dose
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Proportion of Subjects requiring rescue therapy during treatment
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Frequency and severity of adverse events
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Time frame: Week 0 to Week 52 + 14 days follow-up
Incidence and rate of Hypoglycemic events
Time frame: Week 0 to Week 52 + 14 days follow-up
Change in weight
Time frame: Week 0 to Week 26、Week 0 to Week 52
Anti-drug Antibodies
Time frame: Week 0 to Week 52 + 14 days follow-up
Serum INS068 concentration
Time frame: Week 0 to Week 52
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
Time frame: Week 0 to Week 26 、Week 0 to Week 52