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Clinical Trial Details

Trial ID: L4886
Source ID: NCT05699408
Associated Drug: Ins068 Injection
Title: To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
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 and 52 weeks of treatment, 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, 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, Week 0 to Week 26, Week 0 to Week 52|Change in HbA1c, Week 0 to Week 52|per-breakfast SMPG, Week 0 to Week 26 、Week 0 to Week 52|8-point SMPG profiles, Week 0 to Week 26 、Week 0 to Week 52|Average daily Insulin dose, Week 0 to Week 26 、Week 0 to Week 52|Proportion of Subjects requiring rescue therapy during treatment, Week 0 to Week 26 、Week 0 to Week 52|Frequency and severity of adverse events, Week 0 to Week 52 + 14 days follow-up|Incidence and rate of Hypoglycemic events, Week 0 to Week 52 + 14 days follow-up|Change in weight, Week 0 to Week 26、Week 0 to Week 52|Anti-drug Antibodies, Week 0 to Week 52 + 14 days follow-up|Serum INS068 concentration, Week 0 to Week 52|Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs), Week 0 to Week 26 、Week 0 to Week 52
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 513
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-31
Completion Date: 2024-11-23
Results First Posted:
Last Update Posted: 2025-02-18
Locations: Peking University People's Hospital, Beijing, Beijing, 100044, China
URL: https://clinicaltrials.gov/show/NCT05699408