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Clinical Trial Details

Trial ID: L4152
Source ID: NCT04955834
Associated Drug: Insulin Degludec Injection
Title: A Clinical Study of Insulin Degludec Injection in Subjects With Type 2 Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Insulin degludec injection|DRUG: Tresiba®
Outcome Measures: Primary: Change value of glycosylated hemoglobin (HbA1c), Change value of HbA1c from baseline following 26 weeks of therapy, Baseline and 26 weeks | Secondary: Percentage of patients achieving HbA1c ≤7% or HbA1c ≤6.5%, Percentage of patients in each arm achieving HbA1c ≤7% or HbA1c ≤6.5% after 26 weeks of treatment., Baseline, week 26|Change value of HbA1c, Change value of HbA1c from baseline following 14 weeks of therapy, Baseline, week 14|Change value of fasting blood glucose, Change value of fasting blood glucose following 14 and 26 weeks of therapy, Baseline, week 14, week 26|Adverse events (AEs) and serious adverse events (SAEs), AEs and SAEs and their incidence during the 26-week treatment period, and then determine the correlation with the drug, Baseline to week 26|Hypoglycemia, Frequency of severe or symptomatic hypoglycemia during the 26-week treatment period, Baseline to week 26|Immunogenicity, The occurrence of immunogenicity during the 26-week treatment period by detecting Anti-Drug-Antibody(ADA)., Baseline, week 14, week 26|Abnormal findings, Abnormal findings during the 26-week treatment period,including abnormal findings of blood routine test,blood biochemical test as well as other abnormal laboratory findings., Baseline to week 26
Sponsor/Collaborators: Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 344
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-07-27
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2021-09-21
Locations: The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400010, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410013, China
URL: https://clinicaltrials.gov/show/NCT04955834