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Clinical Trial Details

Trial ID: L3473
Source ID: NCT06559722
Associated Drug: Insulin Degludec/Liraglutide Injection
Title: A Trial Investigating the Efficacy and Safety of Insulin Degludec/Liraglutide Injection in Subjects With Type 2 Diabetes
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Insulin Degludec/liraglutide Injection|DRUG: XULTOPHY®
Outcome Measures: Primary: Change from baseline in HbA1c after 26 weeks of treatment, Calculated based on HbA1c level measured in plasma, Baseline, Week 26 | Secondary: Proportion of subjects that achieved HbA1c<7% after 12, 26 weeks of treatment, Calculated based on HbA1c level measured in plasma, Week 12, Week 26|Proportion of subjects that achieved HbA 1c ≤ 6.5% after 12, 26 weeks of treatment, Calculated based on HbA1c level measured in plasma, Week 12, Week 26|Changes from baseline in fasting plasma glucose (FPG) after 12, 26 weeks of treatment, Calculated based on FPG level measured in plasma, Baseline, Week 12, Week 26|Change from baseline in 7-point SMBG values after 12, 26 weeks of treatment, Calculated based on 7-point SMBG values, Baseline, Week 12, Week 26|Change from baseline in body weight after 12, 26 weeks of treatment, Calculated based on body weight measurement, Baseline, Week 12, Week 26|Number of treatment emergent adverse events, Count, From Baseline to Week 27|Number of treatment emergent hypoglycaemic episodes, Count, From Baseline to Week 27|Number of participants with injection site reactions, Count (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration), From Baseline to Week 27|Incidence of anti-drug antibodies (ADA), and neutralising antibodies (if applicable), Calculated based on the values of anti-drug antibodies (ADA), and neutralising antibodies (if applicable), Baseline, Week 12, 26, and 27 (if applicable)|Plasma concentrations of degludec, liraglutide, Calculated based on plasma concentrations of degludec, liraglutide, Baseline, Week 2, 6, 12, 20, 26
Sponsor/Collaborators: Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 510
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-02
Results First Posted:
Last Update Posted: 2024-08-19
Locations:
URL: https://clinicaltrials.gov/show/NCT06559722