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Clinical Trial Details

Trial ID: L2812
Source ID: NCT03520972
Associated Drug: Pb-119 75ug
Title: Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: PB-119 75ug|DRUG: PB-119 150ug|DRUG: PB-119 200ug|DRUG: placebo
Outcome Measures: Primary: Change of glycosylated hemoglobin(HbA1c), Change of HbA1c from baseline value to end of treatment, 12 weeks | Secondary: Percentage of patients achieving HbA1c <7%, Percentage of patients achieving HbA1c \<7% at Week 12, 12 weeks|Percentage of patients achieving HbA1c ≤6.5%, Percentage of patients achieving HbA1c ≤6.5% at Week 12, 12 weeks|HbA1c, Changes of HbA1c from baseline value at Weeks 2, 4, and 8, 2, 4, and 8 weeks|Fasting plasma glucose(FPG), Changes of fasting plasma glucose(FPG) from baseline value at Weeks 2, 4, 8, and 12., 2, 4, 8, and 12 weeks|2-hour postprandial glucose(2-h PPG), Changes of 2-hour postprandial glucose(2-h PPG) from baseline value at Weeks 4, 8, and 12., 4, 8, and 12 weeks|Insulin, Changes of insulin from baseline value at Weeks 4, 8, and 12, 4, 8, and 12 weeks|C-peptide, Changes of C-peptide from baseline value at Weeks 4, 8, and 12, 4, 8, and 12 weeks|Self-monitoring of blood glucose (SMBG), Changes of mean profile and mean increments from baseline value of the 7-point SMBG, 4, 8, and 12 weeks | Other: Body mass index(BMI), Changes of BMI from baseline value at Weeks 2, 4, 8, and 12., 2, 4, 8, and 12 weeks|Waist and hip circumferences and waist-to-hip ratio, Change of waist and hip circumferences and waist-to-hip ratio from baseline value at end of treatment(waist and hip circumferences will be used to calculate waist-to-hip ratio, 12 weeks|Blood pressure(both systolic and diastolic), Changes of blood pressure from baseline value at Weeks 2, 4, 8, and 12., 2, 4, 8, and 12 weeks|Blood lipid, Changes of blood lipid from baseline value at Weeks 2, 4, 8, and 12, 2, 4, 8, and 12 weeks
Sponsor/Collaborators: Sponsor: PegBio Co., Ltd. | Collaborators: Tigermed Consulting Co., Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 251
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-06-05
Completion Date: 2019-07-29
Results First Posted:
Last Update Posted: 2020-01-22
Locations: Peking University People's Hospital, Peking, 100000, China
URL: https://clinicaltrials.gov/show/NCT03520972