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Clinical Trial Details

Trial ID: L3468
Source ID: NCT05348122
Associated Drug: Tg103,Q2w
Title: A Study of TG103 Injection in Type 2 Diabetes Subjects
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: TG103,Q2W|DRUG: TG103,QW|DRUG: Placebo,Q2W|DRUG: Placebo,QW|DRUG: Dulaglutide,QW
Outcome Measures: Primary: Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17, Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17, Baseline through Day 113 | Secondary: Changes in glycosylated hemoglobin (HbA1c) from baseline to week 9, Changes in glycosylated hemoglobin (HbA1c) from baseline to week 9, Baseline through Day57|The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7% at week 9 and 17, The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7% at week 9 and 17, Day57 and 113|Change in fasting plasma glucose (FPG) from baseline to week 9 and 17, Change in fasting plasma glucose (FPG) from baseline to week 9 and 17, Baseline through Day57 and 113|Change in weight from baseline to week 9 and 17, Change in weight from baseline to week 9 and 17, Baseline through Day57 and 113|Mean postprandial blood glucose increment and change in mean postprandial blood glucose from baseline at 7-point Self-monitored Blood Glucose (SMBG) Profile., Mean postprandial blood glucose increment and change in mean postprandial blood glucose from baseline at 7-point Self-monitored Blood Glucose (SMBG) Profile., Baseline through Day113|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile., Change in 7-point Self-monitored Blood Glucose (SMBG) Profile., Baseline through Day113|Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from baseline to week 17., Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from baseline to week 17., Baseline through Day113|Proportion of subjects receiving remedial therapy at week 17, Proportion of subjects receiving remedial therapy at week 17, Day113|Number of TEAEs and SAEs from baseline to week 17, Number of TEAEs and SAEs from baseline to week 17, Day-14 through Day 113|Ctrough will be measured once every 4 week until week 17, Ctrough will be measured once every 4 week until week 17, Day1, 29, 57, 85 and 113|The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (Nab)., The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (Nab)., Day1, 29, 57, 85, 113 and127
Sponsor/Collaborators: Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 240
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-06-15
Completion Date: 2023-11-01
Results First Posted:
Last Update Posted: 2022-06-13
Locations: Gao Huanhuan, Shijia Zhuang, Hebei, 050035, China
URL: https://clinicaltrials.gov/show/NCT05348122