Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
NCT Number: NCT05699408
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Beijing, Beijing Municipality, 100044, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Week 0 to Week 26
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
Time frame: Week 0 to Week 26, Week 0 to Week 52
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% after 26 weeks and 52 weeks of treatment
Time frame: Week 0 to Week 26, Week 0 to Week 52
Time frame: Week 0 to Week 52
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Time frame: Week 0 to Week 52 + 14 days follow-up
Time frame: Week 0 to Week 52 + 14 days follow-up
Time frame: Week 0 to Week 26、Week 0 to Week 52
Time frame: Week 0 to Week 52 + 14 days follow-up
Time frame: Week 0 to Week 52
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial Comparing the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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