The study aims to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with basal insulin compared to insulin Glargine QD for 26weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
423
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
Zhongshan Hospital
Shanghai, Shanghai 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 of treatment
Time frame: Week 0 to Week 26
Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%
Proportion of subjects with HbA1c\<7% and HbA1c≤6.5% after 26 weeks of treatment
Time frame: Week 0 to Week 26
per-breakfast SMPG
Mean and Within-subject variability of pre-breakfast SMPG after 26 weeks of treatment
Time frame: Week 0 to Week 26
8-point SMPG profiles
Time frame: Week 0 to Week 26
Average daily Insulin dose
Average daily Insulin dose after 26 weeks of treatment.
Time frame: Week 0 to Week 26
Proportion of Subjects requiring rescue therapy during treatment
Proportion of subejcts requiring rescue therapy during 26 weeks of treatment
Time frame: Week 0 to Week 26
Frequency and severity of adverse events
Severity (mild, moderate and severe) is assessed by investigator.
Time frame: Week 0 to Week26 +14 days follow-up
Incidence and rate of Hypoglycemic events
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Incidence and rate of of Hypoglycemic events
Time frame: Week 0 to Week 26+14 days follow-up
Change in weight
Change from baseline in weight after 26weeks of treatment
Time frame: Week 0 to Week 26
Anti-drug Antibodies
Number of subjects with Positive Anti-drug Antibodies
Time frame: Week 0 to Week26 + 14 days follow-up
Serum INS068 concentration
To evaluate PK of INS068
Time frame: Week 0 to Week 26
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
Change from baseline in scores of DTSQs after 26 weeks of treatment.
Time frame: Week 0 to Week 26