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Clinical Trial Details

Trial ID: L3449
Source ID: NCT05702073
Associated Drug: Ins068 Injection
Title: To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: INS068 injection|DRUG: Insulin Glargine
Outcome Measures: Primary: Change in HbA1c, Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment, Week 0 to Week 26 | Secondary: Change in FPG(fasting plasma glucose), Change from baseline in FPG after 26 weeks of treatment, 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, Week 0 to Week 26|per-breakfast SMPG, Mean and Within-subject variability of pre-breakfast SMPG after 26 weeks of treatment, Week 0 to Week 26|8-point SMPG profiles, Week 0 to Week 26|Average daily Insulin dose, Average daily Insulin dose after 26 weeks of treatment., Week 0 to Week 26|Proportion of Subjects requiring rescue therapy during treatment, Proportion of subejcts requiring rescue therapy during 26 weeks of treatment, Week 0 to Week 26|Frequency and severity of adverse events, Severity (mild, moderate and severe) is assessed by investigator., Week 0 to Week26 +14 days follow-up|Incidence and rate of Hypoglycemic events, Incidence and rate of of Hypoglycemic events, Week 0 to Week 26+14 days follow-up|Change in weight, Change from baseline in weight after 26weeks of treatment, Week 0 to Week 26|Anti-drug Antibodies, Number of subjects with Positive Anti-drug Antibodies, Week 0 to Week26 + 14 days follow-up|Serum INS068 concentration, To evaluate PK of INS068, 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., Week 0 to Week 26
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 423
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-31
Completion Date: 2024-06-11
Results First Posted:
Last Update Posted: 2025-03-13
Locations: Zhongshan Hospital, Shanghai, Shanghai, 200032, China
URL: https://clinicaltrials.gov/show/NCT05702073