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Clinical Trial Details

Trial ID: L3479
Source ID: NCT04314622
Associated Drug: Supaglutide
Title: A Study of Supaglutide in Chinese Type 2 Diabetes Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Supaglutide|DRUG: Placebo
Outcome Measures: Primary: HbA1c, Change from Baseline in Hemoglobin A1c (HbA1c), Baseline, 7 weeks, 17weeks|Adverse Events, Number of Adverse Events, Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B|Vital Sign, Assessments of Vital Sign, Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B|Laboratory Tests, Assessments of Laboratory Tests, Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B|12-lead ECGs, Assessments of 12-lead ECGs, Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B|Immunogenicity Tests, Assessments of Immunogenicity Tests, Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B | Secondary: HbA1c <7%, Percentage of Participants Achieving HbA1c Target \<7.0%, Baseline, 7 weeks, 17weeks|Glycosylated Albumin, Changes from Baseline in Glycosylated Albumin, Baseline, 7 weeks, 17weeks|Fasting Blood Glucose, Changes from Baseline in Fasting Blood Glucose, Baseline, 7 weeks, 17weeks|Fasting Blood Insulin, Changes from Baseline in Fasting Blood Insulin, Baseline, 7 weeks, 17weeks|Fasting Blood C-peptide, Changes from Baseline in Fasting Blood C-peptide, Baseline, 7 weeks, 17weeks|Blood Lipid, Changes from Baseline in Blood Lipid, Baseline, 7 weeks, 17weeks|Body Weight, Changes from Baseline in Body Weight, Baseline, 7 weeks, 17weeks|Pharmacokinetics (PK): Area Under the Curve, Area Under the Plasma Drug Concentration-Time Curve from Zero to Infinity (AUC0-∞), Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)|Pharmacokinetics (PK): t½ of Supaglutide, Terminal Elimination Half-life in Plasma (t½), Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)|PK: Tmax of Supaglutide, Time to Maximum Plasma Concentration (Tmax), Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A)
Sponsor/Collaborators: Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Collaborators: Shanghai 6th People's Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-04-14
Completion Date: 2021-03-16
Results First Posted:
Last Update Posted: 2021-09-17
Locations: The Affiliated Zhongda Hospital of Southeast University, Nanjing, Jiangsu, 210000, China
URL: https://clinicaltrials.gov/show/NCT04314622