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Clinical Trial Details

Trial ID: L4450
Source ID: NCT05606913
Associated Drug: Dulaglutide
Title: A Study of IBI362 in Participants With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: dulaglutide|DRUG: IBI362
Outcome Measures: Primary: HbA1c change from baseline at week 28, Baseline, 28 weeks | Secondary: percent change from baseline in body weigh, Baseline, 28 weeks|Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline, Baseline, 28 weeks|Change from baseline in HbA1c (superiority), Baseline, 28 weeks|Proportion of subjects with HbA1c <7.0%, Baseline, 28 weeks|Safety,Incidence and severity of adverse events and correlation with study drug;, Baseline to 32weeks|Time to peak plasma concentration (Tmax), Baseline to 28weeks|Time to peak plasma concentration (Cmax), Baseline to 28weeks|area under curve (AUC), Baseline to 28weeks|volume distribution (V), Baseline to 28weeks|half-life (half-life, T1/2, Baseline to 28weeks|clearance rate (clearance, CL), Baseline to 28weeks|To assess changes in PD parameters fasting insulin at different time points before and after administration., Baseline to 28weeks|To assess changes in PD parameters fasting C-peptide at different time points before and after administration., Baseline to 28weeks
Sponsor/Collaborators: Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 731
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-06
Completion Date: 2024-04-09
Results First Posted:
Last Update Posted: 2024-08-23
Locations: China-Japan Friendship Hospital, Beijing, Beijin, 100029, China
URL: https://clinicaltrials.gov/show/NCT05606913