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Clinical Trial Details

Trial ID: L3491
Source ID: NCT06254014
Associated Drug: Exendin-4 Fc Fusion Protein Injection
Title: A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Placebo in T2DM Patients
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Exendin-4 Fc fusion protein injection|DRUG: Exendin-4 Fc fusion protein injection|DRUG: Placebo
Outcome Measures: Primary: HbA1c, Change in glycated hemoglobin (HbA1c) values relative to baseline after 26 weeks of treatment., Baseline, Week 26 | Secondary: The proportion of HbA1c <6.5% and <7%, Proportion of subjects with HbA1c \<7% and HbA1c \<6.5% after 26 and 54 weeks of treatment., Baseline, Week 26,Week 54|HbA1c, Change in HbA1c relative to baseline after 6, 10, 14, 20, 38, and 54 weeks of treatment., Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54|fasting plasma glucose (FPG), Change in fasting plasma glucose (FPG) relative to baseline after 6, 10, 14, 20, 38, and 54 weeks of treatment., Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54|fasting insulin, Change in fasting insulin relative to baseline after 14, 26, and 54 weeks of treatment., Baseline, Week 14,Week 26,Week 54|Homeostatic Model Assessment of Insulin Resistance(HOMA-IR), Change in HOMA-IR relative to baseline after 26 and 54 weeks of treatment., Baseline,Week 26,Week 54|Health Survey Short Form (SF-36), Value of change in Health Survey Short Form (SF-36) scores relative to baseline after 26 and 54 weeks of treatment., Baseline,Week 26,Week 54|blood pressure, Change in blood pressure (sitting) relative to baseline after 26 and 54 weeks of treatment., Baseline,Week 26,Week 54
Sponsor/Collaborators: Sponsor: Beijing Dongfang Biotech Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 270
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2025-12-30
Results First Posted:
Last Update Posted: 2024-08-20
Locations: Peking University People's Hospital, Beijing, Beijing, 100044, China
URL: https://clinicaltrials.gov/show/NCT06254014